Nutraceutical market in India: Thoughts on a right-based regulatory approach

Abstract

The nutraceuticals industry in India has witnessed strong growth, expanding at a CAGR of ~12%–15% in recent years (2020–2023), driven by rising health awareness, increasing disposable incomes, and demand for preventive healthcare. The market, valued at $8–10 billion in 2023, is expected to reach $18–20 billion by 2027, fueled by trends like immunity-boosting supplements, functional foods, and e-commerce penetration. However, the regulatory framework governing this sector remains complex. Nutraceuticals, which fall between food and pharmaceuticals, pose unique challenges regarding their quality, safety and effectiveness. In India, nutraceutical products are categorized as foods and are regulated by the Food Safety and Standards (FSS) Act, 2006. The FSS Authority of India is the primary regulatory body responsible for monitoring the manufacturing and marketing of nutraceuticals in India. Regardless of these efforts, there exists an uncertainty regarding the categorization of nutraceuticals. The main reason is with respect to their therapeutic effect and the form in which they are sold in the market. It closely resembles pharmaceutical products. With the global expansion of these products, it is imperative to ensure their quality and safety. This article critically analyses the current regulatory framework for nutraceuticals in India and also makes a comparative analysis of the regulation of nutraceuticals in various countries. The article also emphasizes the necessity for more rigorous regulation for the manufacturing and marketing of nutraceuticals to ensure the quality and safety of the products, thereby protecting public health.

Introduction

Nutraceuticals are defined as foods fortified or enriched with nutrients, dietary supplements, or herbal products that support health and reduce disease risk. They are bioactive compounds derived mainly from plants, fruits, vegetables and marine sources that provide therapeutic effects beyond nutritional benefits.[1] The COVID-19 pandemic, increased incidence of diabetes, hypertension and obesity, accelerated the growth of the nutraceutical industry. People are using nutraceuticals to avoid the adverse effects of medicines and alternative therapy to costly treatment options.

In India, even though it is sold in the form of medicines, nutraceutical products are categorized as foods and regulated accordingly. They are regulated under the Food Safety and Standards Act, 2006 (FSS Act), and the manufacturing and marketing of these products are monitored by the FSS Authority of India (FSSAI). They are not strictly regulated as that of pharmaceuticals. Some people take nutraceutical products as an alternative to modern medicine. This has resulted in rising demand for nutraceuticals worldwide. At the same time, this consumer behaviour has underscored the need for regulation to maintain the quality and safety of the products. This article provides insights into the concept of nutraceuticals and critically analyses whether nutraceutical products can be categorized as medicines and regulated accordingly.

Concept of Nutraceuticals

Nutraceutical is defined as “a food or a part of food that provides medical or health benefits, including the prevention or treatment of a disease.”[2] Analyzing this concept is in a grey area between food and medicine. These products contain bioactive compounds, phytochemicals and antioxidants that have various health benefits.[3] They have the ability to cure various diseases.[4] These products may range from dietary supplements, genetically modified food products, processed foods and herbal supplements. Some popular nutraceuticals include Echinacea, glucosamine, omega-3, lutein, folic acid, and curcumin. They are available in various forms, such as tablets, capsules, granules, powders, and liquids.[5] These products are widely available in the market and can be conveniently incorporated into the daily routine without any significant lifestyle changes.[3]

Analysis of nutraceuticals, functional foods, and dietary supplements centers on verifying their identity, purity, potency, and safety through targeted techniques. Researchers commonly employ chromatographic methods, mass spectrometry, and an array of spectroscopic approaches to achieve these goals reliably. These methods enable precise characterization of active compounds while detecting contaminants, ensuring product quality aligns with regulatory standards.[6]

Indications for the uses of nutraceutical products

Nutraceuticals play a vital role in enhancing health, maintaining bodily functions, and preventing or managing diseases such as diabetes, cardiovascular disorders, arthritis, and neurological conditions. Supported by clinical evidence, these products–ranging from ginger, omega-3-rich flaxseed, probiotics, and spirulina to fortified vitamins and antioxidants–offer therapeutic benefits like anti-inflammatory, immune-boosting, and metabolic-regulating effects. With growing consumer reliance on nutraceuticals for wellness, the market continues to expand, driven by products like turmeric supplements, fish oils, and herbal extracts. As research advances, nutraceuticals are increasingly recognized as a bridge between nutrition and medicine, offering natural, preventive, and adjunctive therapeutic solutions for modern health challenges.

Nutraceutical Industry: Indian Potential

The global nutraceutical market is experiencing significant growth, driven by rising health consciousness, increasing lifestyle diseases, urbanization, and the growing demand for preventive healthcare–especially post-COVID-19. With the global market valued at USD 591.1 billion in 2024 and projected to grow at a compound annual growth rate (CAGR) of 7.6% (2025–2030),[7] developed regions like Europe, the U.S., and Japan dominate the industry. However, India is emerging as a key player, with its nutraceutical market reaching USD 30.37 billion in 2024,[8] fueled by rising FDI, a booming middle class, and increasing consumer preference for immunity-boosting and wellness products.

The Indian market is segmented into functional foods and beverages (60%) and dietary supplements (40%), with major domestic and international brands like Himalayan Organics, Dabur, Amway, and Abbott leading the way. Innovations, such as marine-based nutraceuticals by CMFRI, further highlight the sector’s potential. As consumers increasingly shift toward natural, preventive healthcare solutions, India’s nutraceutical industry is poised for rapid expansion, offering vast opportunities for businesses and investors in the coming years.

Indian environment, biodiversity and its contribution to the nutraceutical industry

India has diverse landscapes with a wide variety of therapeutic plants. During ancient times, people were more dependent on their environment, and they discovered the healing properties of plants through practical observation.[9] This formed the basis for using plants for therapeutic purposes and led to the development of the traditional medicinal systems. Subsequently, various traditional Indian systems of medicine, such as Ayurveda, Siddha, Unani and Naturopathy, have developed in India. Ayurveda, the oldest and most extensively studied traditional medical system, has helped in the development of modern nutraceuticals. They used medicinal plants for the preparation of medicines for various diseases. This traditional knowledge about the use of a wide variety of plants for therapeutic purposes has played a substantial role in the growth of the nutraceutical industry in India.

India’s diverse geography consists of 15 distinct agro-climatic zones, from the Himalayas to coastal areas, deserts to rainforests. These regions contain different species of medicinal plants which have unique therapeutic properties. According to the National Medicinal Plant Board, India has more than 7000 species of medicinal plants, which offer a unique set of health benefits. As a result, this increased availability of these plant-based raw materials and medicinal plants serves as a substantial resource for the nutraceutical industry. The properties of various medicinal plants are already known to the population, which will make the development of nutraceuticals easy. These plants also bridge traditional and modern healthcare, because for their nontoxic and cost-effective nature. Therefore, India’s potential to produce a wide variety of raw materials and finished products enables India to compete with the large nutraceutical-producing nations.[10]

Need for Regulation of Nutraceuticals

Although nutraceuticals have the potential to provide various health benefits, concerns about their effectiveness and safety are significant. Nutraceuticals, which include dietary supplements, functional foods and herbal products, are often perceived as natural and safe. It is also argued to be an alternative for pharmaceuticals.[11] The real adverse effects and clinical impact of nutraceuticals can be learned only in due course. In this context, it is important to note the adverse effects in the form of toxicity for nutraceuticals.[12] Replacement of medicines with nutraceuticals should be felt as a question to be answered in the long future.

Substantial evidence documents herb–herb, food–herb, and food–drug interactions, with clinical cases demonstrating alterations in drug efficacy, elevated toxicity, as observed with St. John’s wort and anticoagulants or oral contraceptives, and serious adverse events. These interactions arise primarily from phytochemical modulation of metabolic enzymes (e.g., CYP450 isoforms) and transporters, underscoring that “natural” compounds are not inherently safe. Nutraceutical formulations, often comprising multiple botanicals, introduce heightened complexity, potentially yielding synergistic benefits (as in Traditional Chinese Medicine) alongside risks, particularly with medications possessing narrow therapeutic indices, thus necessitating rigorous precaution.[13] Therefore, using nutraceuticals without proper instructions or indications can lead to hazardous cumulative health effects, and it is necessary to do the regulations in the production and selling of the nutraceuticals.

Furthermore, there may be a chance of contamination of the products, incorrect dosage and also adverse effects due to the interaction with other medications. This will affect the health of the people and thereby violate the right to health, which is well recognized as a basic part of the right to life.[14] The right to health is also well established under the Universal Declaration of Human Rights[15] as well as the International Covenant on Economic, Social, and Cultural Rights.[16] As per these legal instruments, every person must have the right to access safe, efficacious and quality products.

However, in most countries, the regulatory framework governing the nutraceutical industry is not as stringent as that of the pharmaceutical industry. As a result, there may be variations in their quality, safety and efficacy. Some nutraceuticals may contain adulterated, spurious or low-quality ingredients. Many nutraceuticals claim health benefits, but these products lack adequate clinical trials and long-term studies to prove their efficacy. This lack of substantial scientific evidence poses a challenge for consumers to analyze the efficacy and safety of various nutraceutical products. Nutraceutical products are readily available in the market. They are over-the-counter products, and consumers can easily access the products for their needs. The presence of adulterated or spurious nutraceutical products violates the fundamental rights to safety and health. As nutraceutical products are for human consumption, it is the duty of the State to implement effective measures to ensure that the products available in the market are safe and efficacious.

It is important to recognize that nutraceuticals also have the ability to interact with other medicines or supplements. Consumers are often not sufficiently informed about the impact of these products on existing medical conditions and their interactions with prescribed medicines. Consuming the products without consulting with a healthcare professional may lead to adverse effects or interactions.[3] Therefore, the consumer must be provided with clear and accurate information regarding the products to make their own choices.

Another concern is that some nutraceutical products may make misleading or exaggerated claims in order to increase production and marketing. This attracts the provisions of the Consumer Protection laws.[17] Nowadays, various advertisements relating to the therapeutic properties of nutraceuticals or health supplements are there in the media. In addition, there may be a lack of adequate transparency regarding the active ingredients used in the manufacturing of products. Such practices not only undermine the trust of the consumer but also raise ethical concerns within the industry. The safety and effectiveness of these products cannot be ensured due to inadequate regulation and monitoring. All these aspects highlight the need for a stringent regulatory mechanism to ensure the quality, safety, and efficacy of nutraceuticals before they are marketed, thereby upholding the rights of consumers.

Ensuring data reliability and integrity (DI) in nutraceutical formulations is critical, as the industry operates in a unique regulatory space between food and pharmaceuticals. The principles align closely with ALCOA + principles (attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, and available), but must be tailored to the specific challenges of the industry.[18]

Nutraceuticals: Whether drug or food

As far as the regulation of nutraceuticals is concerned, the main question that arises is regarding their categorization. Based on various factors, it is evident that they are more closely linked to pharmaceutical products than food products. Therefore, it can be classified as medicine rather than food product and should be regulated accordingly.

However, in Canada and Australia, it is regulated as a category of drug rather than a food.[19] Health Canada defines nutraceuticals as “products prepared or derived from foods, but sold in medicinal forms not typically associated with foods.”[20] In Canada, the majority of nutraceutical products are considered Natural Health Products (NHPs), which are a subclass of drugs, and are regulated as per the NHPs Regulations (NHPRs), 2004. In Australia, nutraceutical products are considered therapeutic goods and are regulated by the provisions of the Therapeutic Goods Act of 1989. In the European Union (EU), the legal classification of nutraceuticals is based on their therapeutic effects. If the product only maintains the healthy organs of the body, it is categorized as food. However, if the product alters or modifies the physiological processes of the body, it is likely to be classified as a medicinal substance.[21] Therefore, nutraceutical products can be considered as medicine mainly for two reasons. First, they can be used to prevent or treat a condition or disease. Second, it can be administered to restore, correct or modify physiological functions in the human body.

The core challenge for nutraceutical formulators is to transform a diverse set of inherently unstable, poorly soluble, and variable natural actives into a stable, potent, predictable, and bioavailable dosage form–all while maintaining cost-effectiveness and using only regulatory-approved (GRAS) ingredients. This requires a deep understanding of material science, chemistry, and pharmaceutics.[22]

While determining whether nutraceutical products should be categorized as drugs or foods, there are four perspectives that can be used to analyze the nature of nutraceuticals.

Claim-based approach

A product can be categorized mainly based on the claim made by that particular product. The nutraceutical product generally makes claims about its effect on a specific medical condition. The product can be used to treat or prevent any disease or medical condition, for example, managing diabetes, reducing cholesterol, etc. In this scenario, this is considered a medicinal product. If the product claims or is intended to be used for general health benefits such as boosting immunity, improving digestion, and promoting joint health, it can be considered a food, as it does not make any disease-related claims. However, when nutraceutical products make claims regarding the therapeutic effect, they should be substantiated with scientific evidence. For this purpose, the product must have to undergo a well-controlled clinical trial process as that of drugs, to ensure the safety and efficacy of the product.

Physiology-based approach

The next approach is whether the physiological process can determine the status of the product. Nutraceuticals are bioactive compounds that provide health benefits beyond basic nutrition. If the product has a significant physiological effect on the body, which is strong and targeted at a specific medical condition, for example, lowering blood sugar in diabetes, controlling cholesterol levels in cardiovascular diseases and reducing the symptoms of arthritis, it can be considered as a drug. However, the physiological effect of the nutraceutical product must be proven and substantiated with clinical evidence.

Conceptual approach

Another aspect is whether the definitions of nutraceuticals can be considered to determine the regulatory pathways. Dr. Defelice defined nutraceutical as a food or a part of food that provides medical or health benefits. It helps in the prevention or treatment of a disease. Based on this definition, if the product has the potential to provide any medical benefits to the human body, such as the prevention or cure of a particular disease, then it should be considered a medicinal product. However, in the majority of countries, there is no specific definition for nutraceuticals. Nutraceutical products are categorized among other food supplement products and are regulated as foods. For categorizing it as a drug or food, a specific, uniform definition is needed.

Consumer-based approach

The nutraceutical categorization can also be based on the consumer perspective. The customer may not have deep knowledge regarding the technical or legal distinction between food and pharmaceutical products. The categorization of a product by the consumer is mainly based on the intended use and their expectations regarding the benefits of that particular product. Various factors influence consumer decision-making regarding a particular product. The labeling and claims made by the product play a significant role in how customers categorize that specific nutraceutical product. The claims made by the product influence the understanding and expectations of the consumer. The marketing strategy adopted by the product also influences its categorization. If the nutraceutical is marketed as a product for a specific disease, it is observed as having a therapeutic effect and should be considered as a drug. It is imperative that the good effects of nutraceuticals are scientifically proven before it is entering into the market. This can be done through well-controlled clinical studies, which demand drug-based therapeutic standards. It is highly reasonable, under this approach, to classify nutraceuticals as drugs rather than mere food products.

Regulation of Nutraceuticals in India

In 2006, India established the FSS Act, which regulates the manufacturing, storage and sale of all food products, including nutraceuticals. Thus, FSSAI, established under the Act, regulates the production, storage and distribution and also establishes guidelines for ensuring the safety and quality of foods, including nutraceutical products in India. Several regulations pertaining to nutraceuticals have been enacted. Recently in 2022, FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purposes, and Prebiotic and Probiotic Foods) Regulations (FSS [Nutra] Regulation, 2022) were enacted superseding the existing FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.

The efficacy of existing regulation in India

As per the FSS Act, 2006, nutraceutical products are classified as foods that are specially made to meet any specific dietary requirements as a result of some specific disorders or diseases.[23] Dr. Defelic clearly defined it as a food product that provides medical or health benefits that have the potential to prevent or treat various diseases.[2] While analyzing these definitions, it is clear that the definition in the Act is very loosely drafted. The ability of nutraceuticals to prevent or treat diseases is not highlighted in the provisions of the FSS Act and Regulations. Clause 6 (2) of the 2022 Regulation specifies that nutraceuticals are products that provide physiological benefits and help to maintain good health. It is not intended to treat any disease. This provision seems contradictory to the definition given by Dr. Defelice. The ambiguous definition of nutraceuticals and their regulatory aspects is becoming a significant challenge.

This existing legislation addresses various items such as nutraceuticals, health supplements, and foods for special dietary use under one single umbrella. Currently, there is no specific definition for nutraceuticals, and they are treated among other food-derived categories, such as food supplements and fortified foods. There arises a question of whether such comprehensive regulation is sufficient in governing nutraceutical products which are having therapeutic effects or medical advantages apart from the nutritional value.

In addition to that, the products claiming to mitigate any specific diseases shall not come under the purview of the FSS Regulation.[24] Therefore, unlike the other products, if nutraceuticals have the potential to change the physiological condition of the human body, these food regulations shall not apply. It should be classified as a drug and must be regulated accordingly. When it is regulated as a drug, a nutraceutical has to undergo rigorous monitoring, including a clinical trial process, before they enter the market. Once the product has entered the market, the long-term efficacy and adverse events must also be monitored by the concerned authorities.

The existing regulations also specified that these products can be delivered in the form of capsules, tablets, granules, powders, drops, etc. When nutraceutical products are delivered in the form of tablets, capsules, granules, etc., the purity criteria and quality requirements must comply with the requirements specified in the Indian Pharmacopoeia, if the Food Authority does not specify the requirements.[25] Therefore, the nutraceutical products that are mainly delivered in the form of capsules, tablets, granules, powders, etc., must have to comply with the requirements of the Indian Pharmacopoeia.

Clause 5 (12) of the FSSAI (Nutra) Regulation also speaks about the labeling requirements of the products for sale. It is mandated that “not for medical purposes” should be mentioned in the label unless in exceptional cases. The question here arises whether mere labeling as “nutraceuticals” addresses all the concerns of nutraceuticals. Unlike other food-derived products, they cannot be considered mere foods. Nutraceutical products have therapeutic effects. Even though it is a nonprescription product, if it is consumed for a long time, it may have an adverse effect on the health of the people. This will violate the right to health and safety of the consumers. While analyzing the requirements, it is clear that all other warnings expected by the regulation speak about something very similar to those required for drugs. Therefore, it should be considered similar to drugs and should be regulated accordingly.

In addition to that, the health benefits claim that the nutraceutical products may not be substantiated due to the lack of scientific evidence. The scientific evidence to prove the effect of nutraceuticals is very limited when compared to drugs. The existing regulations do not even mention the need for scientific evidence. The therapeutic efficacy of a particular product should be assessed based on the evidence from clinical data.[26] Here arises a concern about how many nutraceutical products are tested for their efficacy or safety. If any product has the potential to change any physiological condition and it is claimed to prevent or treat a particular disease condition, it should be clinically tested as that drug. However, in the case of nutraceuticals, they do not undergo any clinical trial and do not have any adverse impact reporting after entering the market. This may cause false expectations and even violate consumer rights. Therefore, a different approach is needed for nutraceuticals.

To enhance consumer safety as well as to address the regulatory challenges, recently, the Union Government has formed a panel to analyze the possibility of shifting the regulation of nutraceutical products to the Central Drugs Standard Control Organization, the main drug regulatory body in India. The officials also highlighted that because of unclear demarcation, many companies are opting to seek approval from FSSAI for products having therapeutic properties that closely resemble pharmaceutical products.[27] This underscores the need for effective and stringent regulation of nutraceutical products in India.

Furthermore, the Delhi High Court in Sun Pharma Laboratories Ltd. v Ajanta Pharma Ltd.[28] observed that the mere fact that the products are nutraceuticals and not pharmaceuticals in the strict sense, and contain only plant-derived ingredients, is not convincing enough for less stringent tests for passing off. They are similar to pharmaceutical products, and both are used for the improvement of the health of patients. Therefore, the Court is of the view that nutraceuticals should be treated on par with pharmaceuticals and the stringent test applicable to pharmaceutical products would also be applicable to nutraceutical products.

International Approaches in Regulating Nutraceuticals

The nutraceutical market is rapidly growing all over the world. Despite this expansion, there is a lack of a specific definition for the term “nutraceuticals” in the regulations of various countries. Due to the ambiguity regarding the categorization of nutraceuticals, in some countries, they are considered food, and in other countries, they are classified as pharmaceuticals. In many countries, the regulations relating to nutraceutical products are less stringent when compared to pharmaceutical products. In this section, we will analyze the regulation of nutraceuticals in Australia, Canada, the United States and the EU.

Australia

In Australia, Nutraceuticals are categorized as therapeutic goods and are regulated by the Therapeutic Goods Administration (TGA). TGA is a government body established under the Therapeutic Goods Act 1989, for ensuring the safety and efficacy of therapeutic goods, which include medicines, biologics, and medical devices. Most natural products and nutritional supplements are referred to as Complementary medicines. Australia uses a two-tiered system of regulation for all medicines.[18] High-risk medicines have to be registered with the Australian Register of Therapeutic Goods (ARTG) and must be analyzed for their safety, efficacy and quality. While Low-risk medicines may be listed on the ARTG, they must be manufactured in accordance with Good Manufacturing Practices. In 2020, the TGA published Australian regulatory guidelines for complementary medicines. It gives detailed information about regulations and requirements for complementary medicines. The manufacturing of nutraceuticals has to comply with the Good Manufacturing Practices. The registration process for nutraceutical products requires the submission of scientific evidence on safety, efficacy, and quality, including clinical trial data.[29] After the listing of nutraceuticals, the manufacturers or sponsors should do postmarket monitoring and must report the adverse events to the concerned authority.[30]

Canada

In Canada, there is no regulation that specifically deals with nutraceuticals. All foods and drugs are regulated under the Food and Drugs Act and Regulations. Under the Canadian regulatory system, nutraceuticals can be considered as food, a drug or NHP based on the therapeutic claim being made by the product.[18] Therefore, any nutraceutical product that makes a therapeutic claim is considered a drug. The safety, quality and efficacy must be assessed, and it must undergo a rigorous premarket approval process, including the submission of clinical trial data. However, in Canada, the majority of nutraceuticals are considered NHPs that include vitamins, minerals, herbal remedies, amino acids, probiotics, etc. They are regulated by Health Canada as per the NHPRs, 2004. Even though these products are considered a classification of drugs, many of these rigorous requirements are not applicable to drugs. The manufacturers of the NHPs are required to obtain a site license. For this purpose, they have to comply with Good Manufacturing Practices requirements mentioned in the regulations.[31] They are also required to undergo a premarket approval process and also to provide evidence, including clinical trial data, regarding the safety and efficacy of the products. The manufacturer must comply with labeling requirements and also adverse reaction reporting requirements recognized by Health Canada.[19] Therefore, Health Canada can monitor the production and postmarketing procedures.

United States

The majority of nutraceutical products are classified as dietary supplements under the US regulatory system. These products are monitored and governed by the Food and Drug Administration (FDA) under the U.S. Dietary Supplement Health and Education Act (DSHEA), 1994. As per the regulation, dietary supplements have nutritional components that supplement the diet. The DSHEA established labeling regulations and gave permission to the FDA to develop the current GMPs. Unlike the FDA’s regulation of drugs, where the safety and efficacy of the product must be proved before approval, under the DSHEA, FDA premarket approval for nutraceutical products is not mandatory. However, the manufacturers must ensure that the product is safe for people.[18]

European Union

In the EU, nutraceutical products are not regulated by a specific regulation. These products are regulated by several legal frameworks based on the category and claim made by the product. Within the European regulatory framework, in general, the categorization of nutraceuticals is based on how they affect the body. If it only helps in the maintenance of healthy tissues, it may be considered a food product. On the other hand, if it has the ability to modify the physiological process of the body, it may be considered a medicinal product.[32] Regulation (EC) No 178/2002 specifies the general principles and procedures in matters relating to food safety. It establishes the European Food Safety Authority, which is responsible for providing independent scientific advice for EU legislation and policies in the field of food safety.[33] Nutraceutical products may be considered as food supplements or novel foods and are regulated accordingly. The nutritional claims permitted for food are listed in Regulation EU No. 1047/2012.

If the nutraceutical products make a claim to treat or prevent any disease, they are considered a medicinal product and regulated accordingly. Regulation (EC) No 726/2004 lays down the procedures for the authorization and supervision of medicinal products and for establishing a European Medicines Agency which plays a crucial role in medicine regulation and approval. The products have to undergo a rigorous monitoring process, such as a clinical trial process, before entering the market.

Following the withdrawal of the UK from the EU, a report was issued by UK’s Taskforce on Innovation, Growth and Regulatory Reform where one of the recommendations to introduce a separate regulatory framework for nutraceuticals.[34] The report highlights that a separate legal framework is necessary to address the lack of a clear regulatory framework, mainly for verifying and authorizing therapeutic claims made by nutraceutical products. This was again highlighted in the Parliamentary Group on Access to Medicines and Medical Devices Report.[34]

Conclusion

There is no uniform or specific definition for nutraceuticals globally. There are no international standards for the regulation of nutraceuticals. However, the nutraceutical market is expanding rapidly worldwide. The major concern regarding nutraceuticals is whether they are considered as food or pharmaceutical products. In the regulatory framework of the majority of countries, nutraceuticals do not have a specific definition that is different from the food-derived categories. Despite their therapeutic effect, they are considered as one among them and are regulated accordingly. In India, the scenario is the same. Nutraceutical products are regulated as one among food-derived products and are monitored by the FSSAI. It is regulated by the FSS Act, 2006 and the FSS (Nutra) Regulation, 2022.

The information regarding the nutraceutical product remains ambiguous. The health benefits they claimed may not be properly substantiated by scientific evidence. The exaggerated claims and misleading advertisements regarding nutraceutical products may induce false expectations, thereby violating the rights of consumers. If a product claims a therapeutic effect, it should be substantiated by scientific evidence such as clinical trials. The safety and efficacy of the product should be examined. Nutraceutical products are over-the-counter medicines, and the consumer can access them easily. There may be substandard and spurious nutraceutical products available in the market. The prolonged use of such products may adversely affect the health of people and thereby violate the right to health. Stringent measures should be implemented to protect the health of the consumers. From the above discussions, it is clear that the existing regulatory framework for nutraceuticals in India is not adequate in safeguarding the rights of the consumers.

From the international perspectives discussed, three models for the regulatory framework can be identified. One considers nutraceuticals as food and is regulated accordingly. The second considers nutraceuticals as drugs or medicine, and the third approach is to classify them with an exclusively distinct set of regulations. The third model will be purely based on the claims made by the product, and it demands further classification of regulation. Which model among the three will be ideal for India is the first and foremost perplexing question. The economic and social conditions of India need to be considered before making a decision. The poverty, illiteracy, lack of consumer awareness among the masses and awareness about rights may force us to opt for a stringent legal framework for regulating nutraceuticals in India.

The Indian nutraceutical industry plays a vital role in the global nutraceutical market, and the global demand for nutraceuticals is rising rapidly. This emphasizes the need for a well-established regulatory framework in India to ensure the efficacy, safety and quality of nutraceutical products. While these products claim therapeutic effects, which include treatment or prevention of diseases, they should be regulated as same as that of drugs. The implementation of stringent regulation as that of drugs, protects customers from misleading claims or substandard products, thereby safeguarding the rights of customers. While framing regulation for nutraceutical products, it is necessary to adopt a rights-based approach. This approach ensures a harmonious balance between promoting innovation, safeguarding public health and protecting individual rights. It helps to prioritize the right to health which includes access to safe, effective and quality nutraceutical products. Furthermore, it also ensures accurate information and empowers consumers to make informed decisions. At the same time, it also encourages manufacturers to innovate and develop products that comply with ethical and regulatory standards. This right-based approach to the regulation of nutraceuticals facilitates the growth of the Indian nutraceutical market globally.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.