Journal of Young Pharmacists, 2023; 15(4):595-603.

https://www.jyoungpharm.org Review Article

Nutraceuticals: Regulatory Landscape and Market Dynamics

in the Indian Scenario
Lakshmi Prasanthi Nori, Potti Sowmya, Tippa Madhusree, Kalidindi Venkateswara Raju*
Department of Regulatory Affairs, Shri Vishnu College of Pharmacy, Kovvada, Andhra Pradesh, INDIA.

Correspondence:
ABSTRACT Dr. K. Venkateswara Raju M. Pharm,
Numerous diseases can be prevented and treated with the help of Nutraceuticals. They Ph.D
have become an integral part of daily food intake for every human due to the increase in Department of Regulatory Affairs, Shri
lifestyle-related health issues. Ensuring the enforcement of safety and quality standards is of Vishnu College of Pharmacy, Kovvada,
utmost importance, particularly considering the widespread global usage of vitamins, minerals,
Andhra Pradesh, INDIA.
fatty acids, prebiotics, probiotics, and herbal supplements for both preventive and therapeutic
Email: venkateswararaju.k@svcp.edu.in
purposes. The necessity for the development of such regulatory guidelines has been further
highlighted by the fast-growing global Nutraceutical business. Even though rules in the US,
UK, and Europe have been simplified and made more conductive to growth of Nutraceutical Received: 27-06-2023;
product ecosystem, the Indian Nutraceutical companies and the regulatory landscape are still Revised: 20-07-2023;
in their nascent stage and have a lot of room to grow and compete with other international Accepted: 20-08-2023.
organisations. India's Nutraceuticals industry is expanding quickly, and several measures have
been made to position the country as a major role in the future of the sector.

Keywords: Nutraceuticals, Vitamins, Minerals, Global Nutraceutical business, International

organisations.

INTRODUCTION
Dr. Stephen DeFelice coined "Nutraceuticals" as a term in 1989, Chronic heart disease: Nutritional supplements can play a
and in 1994, he defined them as substances that can be considered supportive role in managing chronic heart disease by providing
part of food or food and provide relief for medical ailments as essential nutrients that support cardiovascular health. They may
well as health benefits, that includes disease prevention and help regulate blood pressure, improve cholesterol levels, and
treatment. Nutraceuticals encompass a wide range of substances, reduce inflammation.
including minerals, amino acids, vitamins, herbs, botanicals,
Arthritis: Some Nutraceuticals, such as glucosamine and
essential oils, dietary substances, and natural substances of plant
chondroitin, are commonly used for managing symptoms of
and animal origin. These nutritional supplements are limited
arthritis. These substances are believed to promote joint health,
to the products which are to be administered through the oral
reduce inflammation, and alleviate pain associated with arthritis.
route as tablet, capsule, granules, and powder, liquid, or soft
gel.1 Nutritional supplements are used in the following disease Hypertension: Certain nutritional supplements, including
treatment or their prevention, and they include; coenzyme Q10, omega-3 fatty acids, and potassium, have been
studied for their potential blood pressure-lowering effects.
Anti-diabetic: Nutritional supplements are used to manage
They may be used as adjuncts to lifestyle modifications and
diabetes by providing additional nutrients that support blood
conventional treatments for hypertension.
sugar regulation and improve insulin sensitivity.
It is important to note that while Nutraceuticals can offer
Anti-cancer: Certain Nutraceuticals have been studied for their
potential health benefits, their effectiveness and safety may vary.
potential anticancer properties. They may possess antioxidant,
It is advisable to consult with healthcare professionals before
immune-enhancing anti-inflammatory properties, and that help
starting any new dietary supplement regimen, especially for
in the treatment and prevention of cancer.
individuals with pre-existing medical conditions or those taking
other medications.
DOI: 10.5530/jyp.2023.15.84

Advantages of Nutraceuticals
Copyright Information :
Copyright Author (s) 2023 Distributed under Enhanced Health Benefits: Nutraceuticals offer additional health
Creative Commons CC-BY 4.0 benefits beyond basic nutrition. They are designed to provide
Publishing Partner : EManuscript Tech. [www.emanuscript.in]
specific nutrients, bioactive compounds, or herbal extracts that

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 Nori, et al.: Regulatory Landscape of Nutraceuticals

can support overall health, boost immunity, improve bodily Ethical Concerns: Some Nutraceutical products raise ethical
functions, and address nutritional deficiencies. concerns due to misleading claims, exaggerated marketing
tactics, or inadequate transparency regarding ingredients
Preventive Approach to Healthcare: Nutraceuticals promote a
and manufacturing processes. Such practices can undermine
preventive approach to healthcare. They can be used proactively
consumer trust and pose ethical dilemmas.
to support health and well-being, potentially reducing the risk of
chronic diseases and improving overall quality of life. Bioavailability: Due to issues in bioavailability, even before
Natural and Plant-Based Ingredients: Many Nutraceutical having any therapeutic effect, they are quickly evacuated from
products derive their ingredients from natural sources such as the human body.2
plants, herbs, fruits, and vegetables. These products often contain Impact of the placebo effect: Consumers may sometimes
bioactive compounds, antioxidants, and phytochemicals that may misinterpret the effectiveness of dietary supplements in treating
have beneficial effects on health. The use of natural ingredients illnesses, especially when the body has a natural ability to heal
appeals to individuals seeking alternative or complementary itself.
healthcare options.
Product quality concerns: Nutraceuticals marketed
Convenience and Accessibility: Nutraceuticals come in various internationally often make claims of using organic ingredients
forms such as capsules, tablets, powders, liquids, and functional and natural chemicals. However, the safety and effectiveness of
foods or beverages. They are readily available and can be easily these products may be compromised due to a lack of regulation
incorporated into daily routines without significant lifestyle and oversight.
changes.
Potential for Interactions: Their impact on pre-existing medical
Personalized Nutrition: Nutraceuticals offer the flexibility of conditions and potential interactions with prescribed medications
personalized nutrition. With a wide range of products available, is often not adequately communicated to consumers. This lack
individuals can select supplements that target specific health of information poses potential risks to individuals who rely on
concerns or nutritional requirements. This customization allows Nutraceuticals for their health.
for tailored approaches based on factors such as age, gender,
lifestyle, and specific health conditions. When considering Nutraceuticals, it is important to approach
them critically, seek reliable information, and make informed
Disadvantages of Nutraceuticals decisions based on individual needs and consultation with
Limited Regulation: The Nutraceutical industry lacks stringent healthcare professionals. Nutraceuticals should be viewed as a
regulation compared to the pharmaceutical industry. This complementary approach to a balanced diet and healthy lifestyle,
can result in inconsistencies in quality, safety, and efficacy rather than a substitute.
among different products. Some Nutraceuticals may make
unsubstantiated claims or contain adulterated or low-quality HISTORY OF FOOD REGULATIONS IN INDIA
ingredients. Regulations for Food products in India started in the early
Insufficient Scientific Evidence: While certain Nutraceuticals 20th century when the British colonial government introduced
have shown health benefits through scientific research, many several laws and regulations aimed at control of food quality and
products lack adequate clinical trials and long-term studies ensuring safety. Here is a concise summary of the key milestones
to support their claims. Limited scientific evidence makes it in emergence and evolution of regulations for Food Products in
challenging for consumers to evaluate the effectiveness and safety India:
of various Nutraceutical products. “Prevention of Food Adulteration Act, 1954”: This act touted as
Potential Interactions and Side Effects: Nutraceuticals, like any the first comprehensive legislation in post-independence India
other bioactive substances, have the potential to interact with that aimed to prevent food adulteration and establish standards
medications or other supplements. Consulting with a healthcare for food quality. It also mandated the establishment of Central
professional before starting a new Nutraceutical regimen is Food Laboratory and State Food Laboratories for testing
crucial to ensure compatibility and minimize the risk of adverse purposes.
effects or interactions.
Food Safety and Standards Act, 2006: Replacing the Prevention
Cost Considerations: Nutraceuticals can be more expensive of Food Adulteration Act, this act modernized India's food
compared to regular dietary supplements or traditional food regulatory framework. It established the FSSAI as the central
products. The higher cost may limit accessibility for individuals authority responsible for setting standards, regulating food safety,
with lower incomes or in developing regions. and overseeing enforcement across the country.

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Food Safety and Standards (Amendment) Act, 2011: This • “Environmental protection Act, 1986”
amendment act brought significant changes to the FSS Act, • “Milk and milk products order, 1986”
2006. It introduced stricter penalties for food adulteration and
non-compliance, expanded the scope of FSSAI's authority, and • “Pollution control Act, 1986”
enhanced its regulatory powers. • “Agriculture produce act”
“Food Safety and Standards (Labelling and Display) Regulations, • “Industrial license”
2011”: These provided guidelines for labelling and display of
“packaged food products”. They mandate the disclosure of
• “Vegetable oil product control order, 1998”
information such as nutritional content, ingredients, allergens,
In 1998, the Prime Minister's council on trade and industry
and vegetarian/non-vegetarian symbols on food labels.
established a working group on food and agriculture industries,
“Food Safety and Standards (Packaging and Labelling) which recommended the establishment of a unified legislation
Regulations, 2011”: These specify packaging requirements for under a single food regulatory authority. Experts and members
food products, including use of food-grade materials, proper of the Standing Committee of Parliament also advocated for the
labelling, and guidelines for packaging design and printing. consolidation of existing food laws under a single regulatory
“Food Safety and Standards (Contaminants, Toxins, and Residues) body responsible for public health and food safety in India.
Regulations, 2011”: These guidelines establish maximum limits This move aimed to streamline the regulatory landscape and
for contaminants, toxins, and residues in food products to ensure eliminate multiple layers of control over food. Furthermore, there
consumer safety. They cover substances such as heavy metals, was a specific emphasis on addressing the Nutraceutical and
pesticides, mycotoxins, and veterinary drug residues. functional food segment, which had great potential but lacked
clear definitions and implications for consumer health. In 2002,
“Food Safety and Standards (Import) Regulations, 2017”: These a national nonprofit association was formed with the primary
guidelines govern the import of food products into India. They objectives of ensuring that every food manufacturing company
establish standards and procedures for inspection, sampling, and provides scientific-based support for their products to protect
testing of imported food items to ensure compliance with Indian consumers and promoting a regulatory environment that fosters
food safety standards. the growth of the industry while safeguarding consumer interests.
These milestones represent key developments in the history of The “Indian Food Safety Standard Bill” in 2005 eventually became
food regulations in India. Additional regulations, standards, and into law, having an important impact on our nation's food
guidelines have been introduced over the years to address specific processing business. This led to the enforcement of the “Indian
aspects of food safety, labelling, hygiene, and quality control. The Food Safety and Standards Act in 2006”, which aimed to achieve
FSSAI plays an important role in regulation of food industry two main objectives: the implementation of a single comprehensive
and safeguarding the safety and quality of food consumed by the statute governing the food sector and the promotion of scientific
Indian population. advancements in the food processing industry.
India, faces challenges in the growth of its food market, the
reasons being inadequate infrastructure, logistical issues, and
INDIAN NUTRACEUTICAL MARKET
stringent food regulations. These barriers are particularly evident The Nutraceutical market is currently dominated by the USA,
in the low level of processing of perishable agricultural products, Japan, and Europe, which collectively hold over 90% of the global
which stands at only around 2% compared to 80% in the United market. However, as these markets get closer to maturing, industry
States. participants are turning their attention to emerging markets,
During the mid-1990s, India's food processing sector became specifically those in the Asia Pacific area, among them India. The
entangled in a complex web of regulations, including various Indian Nutraceutical sector had only 2% of the worldwide market
state laws and national legislation such as: in 2017 and is expected to be worth $5 billion by the year 2019.
However, significant growth is anticipated in the coming years,
• “Export Act, 1963” with projections indicating that the Indian market will expand to
• “Solvent extracted oil control order, 1967” $11 billion by 2023, exhibiting a Compound Annual Growth Rate
(CAGR) of 21%. By 2023, India is anticipated to hold a minimum
• “The insecticide Act, 1968” of 3.5% of the worldwide market for Nutraceuticals. The
• “Meat food products order, 1973” Nutraceutical industry in India encompasses the entire ecosystem
involved in the manufacturing, distribution, and consumption of
• “Prevention of food adulteration Act, 1954”
Nutraceutical products within India. Nutraceuticals are products
• “Bureau of Indian standards Act, 1986” that combine the benefits of nutrition and pharmaceuticals, often

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Table 1: Top Nutraceutical companies in India. Nutraceuticals available in the Indian market. Overall, the Indian
Company Description Nutraceutical market presents significant opportunities for
Himalaya Drug A leading Indian company offering both domestic and international companies due to the growing
Company a wide range herbal and natural consumer demand for health and wellness products. The market
healthcare products. is expected to continue its growth trajectory in the coming years
Dabur India Ltd., Well-known consumer goods company as more consumers prioritize preventive healthcare and seek
with a diverse Nutraceutical portfolio natural and holistic approaches to well-being. Functional foods
based on ayurvedic principles. and drinks and dietary supplements make up the two main
Amway India Global direct-selling company with segments of the virtually two-billion-dollar Indian Nutraceutical
Enterprises a wide range of health and wellness industry.
products, including Nutraceuticals. Functional Beverages and Foods: 60% of the market share
Patanjali Ayurved Renowned Indian brand specializing in is made up by this segment. The World Health Organisation
Ltd., ayurvedic products; including a range (WHO) defines fortified food as processed food that has had
of Nutraceutical offerings. micronutrients added. Sports beverages that are fortified juices,
Baidyanath Group Trusted ayurvedic company fortified beverages, fortified foods and energizers are just a few
manufacturing various Nutraceuticals examples of the many products that fall under the category of
and herbal supplements for over a
functional foods and beverages. The nutraceutical segments data
century.
in India is given in Table 2.
Sun Pharmaceuticals One of India’s largest pharmaceutical
Industries companies offering Nutraceutical Dietary Supplements: The remaining 40% of the Indian
products adhering to high quality Nutraceutical business is made up of dietary supplements. This
standards. category includes various types of supplements such as vitamins
and minerals, herbal supplements, protein supplements, and
providing health benefits beyond basic nutrition. The Indian
even traditional products like CHAWANPRASH.
Nutraceutical market has been experiencing significant growth
in recent years. Factors such as increasing health consciousness, The two major manufacturers and consumers are the United
rising disposable incomes, changing lifestyles, and a growing States of America and Europe. Due to rising disposable incomes
middle class have contributed to the market's expansion. and thus greater living standards in these nations, demand is,
Additionally, the COVID-19 pandemic has further accelerated however, expanding strongly in other emerging markets as well.
the demand for Nutraceutical products as people have become According to a report by Variant Market Research, the global
more focused on boosting their immunity and overall well-being. Nutraceuticals market is projected to reach a value of $340
The market includes various types of Nutraceutical products, billion by 2024. From 2016 through 2024, this Corresponds to an
including dietary supplements, functional foods, functional Annualised Growth Rate (CAGR) of 7.2%. According to Grand
beverages, and herbal extracts. Dietary supplements, such as View Research's Global Nutraceuticals Industry Report, the
vitamins, minerals, and protein powders, are among the most industry will grow at an 8.3% Annualised Growth Rate (CAGR)
popular products in the market. Functional foods and beverages to reach $722.49 billions of dollars by 2027.
are fortified with additional nutrients or bioactive ingredients to
provide health benefits beyond basic nutrition. Herbal extracts, Critical problems faced by India's Nutraceutical
derived from traditional Indian medicinal plants, are also widely market
used in Nutraceutical products. Various existing laws pertaining to food and Nutraceutical
hygiene and regulations have been integrated under the FSSAI.
Several domestic and international companies operate in the
However, specific restrictions have not yet been put into place,
Indian Nutraceutical market. Some prominent Indian companies
and the government actively seeks for thoughts on how to
include Himalaya Drug Company, Dabur India Ltd., Amway India
establish them. Currently, the tax rate on Nutraceuticals and
Enterprises Pvt. Ltd., and Patanjali Ayurved Ltd., International
health supplements is 18%, with some categories being taxed at a
players such as Abbott Laboratories, Nestlé, and Herbalife
rate of 28%. Compared to the prior tax rate of 12%, the additional
are also actively involved in the market. The top nutraceutical
levying has led to higher expenses for these goods.
companies in India can be seen in Table 1. The Food Safety and
Standards Authority of India (FSSAI) is responsible for regulating Additionally, the absence of a streamlined system for establishing
Nutraceuticals in India. Under its authority, the FSSAI establishes new plants for Nutraceutical product manufacturing poses
guidelines and regulations pertaining to the manufacturing, challenges for new entrants in this field. The lack of regulations
labeling, and marketing of Nutraceutical products. The primary also hinders their eligibility for subsidies and incentives, further
objective of these regulations is to ensure the safety and quality of complicating their entry into this relatively uncharted territory.

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Table 2: Nutraceutical Market Segments in India. Nutraceutical market. However, there are several other factors and
Segment Description opportunities that are poised to further boost the Nutraceutical
Dietary Includes vitamin, minerals, herbal market in the future. These include:
supplements supplements, protein powders, and other Growing awareness about preventive healthcare: There is an
Nutraceuticals designed to supplement the
increasing awareness among individuals about the importance
diet and provide additional nutrients.
of preventive healthcare, given the rising prevalence of
Functional Food products fortified with additional lifestyle-related diseases. Nutraceuticals, which offer health
foods nutrients or bioactive ingredients to offer
benefits and disease prevention through natural ingredients,
health benefits beyond basic nutrition.
Examples include fortified cereals. are being recognized as a valuable tool for proactive health
management. This heightened awareness contributes to the
Functional Beverages formulated with added functional
beverages ingredients such as probiotics, antioxidants, growth of the Nutraceutical market.
and herbal benefits. Examples include Aging population and demand for healthy aging solutions: The
fortified. global population is experiencing rapid aging, resulting in a higher
Herbal extracts Extracts derived from traditional demand for solutions that promote healthy aging and address
Indian medicinal plants used in various age-related health issues. Nutraceuticals catering to joint health,
Nutraceutical products, including herbal
cognitive function, cardiovascular health, and overall vitality are
supplements, oils, and tonics.
likely to witness significant growth as the aging population seeks
Trends and demand changes natural and safe alternatives to maintain their health.
The market for Nutraceuticals has surpassed that for supplements, Consumer preference for natural and organic products:
which was previously dominated by pharmaceuticals, with a Consumers are increasingly inclined towards natural and
significant 67% share. The growing consumer preference for organic products across various sectors, including healthcare.
Nutraceuticals can be attributed to the increased awareness and Nutraceuticals produced from natural resources, like herbs,
responsiveness of the public towards health-related issues. Recent botanicals, and plant extracts, are perceived as safer and more
estimates suggest that the southern and eastern regions of India desirable than their synthetic counterparts. This consumer
have the highest concentrations of the Nutraceutical market, preference for natural and organic products will act as a driving
which is also slowly gaining appeal in rural areas. This pattern has force for the growth of the Nutraceutical market.
been influenced by the rural population's increasing awareness
about diseases arising from flawed lifestyle habits. The demand for Technological advancements in product development: Ongoing
Nutraceuticals is expected to experience substantial growth due advancements in technology, such as encapsulation techniques,
to the rising emphasis on preventive healthcare and the increasing Nano emulsion, and novel delivery systems, are revolutionizing
need for medical treatments. As a result, there is a growing the Nutraceutical industry. These technological innovations
demand for products that incorporate Nutraceutical ingredients. enhance the stability, bioavailability, and targeted delivery of
Manufacturers and marketers within the Nutraceutical industry Nutraceutical ingredients, making them more effective and
are assuming the role of educating consumers by offering appealing to consumers. The integration of technology in product
comprehensive information about their products, including development fuels expansion in Nutraceutical market.
their benefits and their contributions to promoting overall health
Personalized nutrition and customization: The concept of
and wellness. This approach aims to establish transparency
personalized nutrition is gaining momentum as individuals
and credibility among consumers, ultimately strengthening the
recognize that their nutritional needs vary based on factors like
Nutraceutical category as a segment of the market for health and
age, genetics, and lifestyle. Nutraceuticals offer the potential for
wellness. Players in the industry are actively pursuing a variety
customization, allowing individuals to address their specific
of activities. To further enhance the Nutraceutical market.
health concerns and optimize their well-being. The ability to
These include focusing on improving product quality standards,
increasing transparency, and offering competitive pricing for tailor Nutraceutical products to individual needs will drive their
innovative products. These efforts contribute to the overall demand and further market growth.
development and growth of the Nutraceutical industry. E-commerce and direct-to-consumer channels: The rise of
e-commerce platforms and direct-to-consumer channels has
OPPORTUNITIES significantly facilitated access to a wide range of Nutraceutical
Due to an increase in bad eating habits, sedentary lives, low levels products. Consumers can now conveniently purchase
of physical exercise, the prevalence of lifestyle-related diseases Nutraceuticals online, bypassing traditional retail channels. This
has increased. This in turn, has led to a significant growth in the enhanced accessibility, coupled with the convenience of home

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delivery, has expanded the consumer base and contributed to the Application form B of schedule 2 and license obtained in form C.
expansion of the Nutraceutical industry.
Self-attested declaration form.
Government support and regulations: Governments worldwide
are increasingly acknowledging the prospective advantages of Copies of the following documents
dietary supplements in promoting public health and wellness. There is a chance that some of the content is contradicting or
Consequently, there is a growing emphasis on implementing confusing as India's Nutraceutical regulation develops with the
regulations and policies to guarantee the security, effectiveness, recent introduction of FSSA, but this needs to be streamlined
and standard of Nutraceutical items. Such support from for the Indian sector to take shape.6-11 Documents need to be
regulatory authorities instills consumer confidence and fosters submitted with new licence or import licence applications to the
market growth. State or Central Licensing Authority.
Integration of Nutraceuticals in conventional healthcare: • Form A.
Nutraceuticals are progressively being integrated into mainstream • Form B.
healthcare as complementary or alternative therapies. Physicians
and healthcare professionals are recognizing the potential • Blueprint/layout plan of the processing unit.
benefits of Nutraceuticals in preventing and managing certain • List of directors.
health conditions. This integration provides additional avenues
for the growth of the Nutraceutical market. • Name and list machineries to be used in the process.
• Photo id and address proof.
Registration process of Nutraceuticals in India
• List of food category desired to be manufactured.
In India the registration of Nutraceutical is required for the
marketing of the product in Indian market. The FSS act (2006) • Authority letter with name and address of responsible
gives the procedure for the registration of the Nutraceutical person analysis report.
products, but there is no standard format is available for the
• Proof of possession of premises.
purpose.3 The Nutraceutical companies in India struggles a lot for
the approval of the product due to the lack of the proper roadmap • Partnership deed/affidavit/memorandum and articles.
for the registration of the products.4 • NOC from manufacturer.
The Food Safety and Standard Rules, 2011 were released in • Food safety management system plan or certificate.
May 2011 by the Food Safety and Standards Authority of India
(FSSAI). These regulations include thorough guidelines for • Source materials.
numerous facets of the food industry, such as standards for food • Pesticide residues report of water.
additives and products, packaging and labelling practises, and
licencing and registration of food firms and goods. On August
• Recall plan.
5, 2011, these regulations were put into effect throughout the • NOCs.
nation. This implementation created a single legal framework
with competent authorities in charge of regulating the nation's Despite the implementation of various regulations and standards
production, distribution, and sale of food items. According to in the food industry, there remains a lack of clarity regarding
FSS regulations, 2011. the registration process for Nutraceuticals and their additives.
Therefore, business owners intending to market Nutraceutical
a) To market food items in India, it is necessary to register a
products in the country are facing several obstacles and challenges,
manufacturing facility and receive a manufacturing licence
according to the current definition of drugs, regulatory authorities
(Form A/B; obtained from the state licencing authority, except
are categorizing Nutraceutical products, particularly those
for those listed under Schedule I).
available in tablet form or as liquid orals containing vitamins and
b) Any food or food product import into the nation requires minerals, under the drug category. Any product contained in a
an import permit, which must be secured from the Central gelatin capsule is viewed as a drug since the empty gelatin capsule
Licencing Authority. The following are the documents required is thought to meet the definition of a drug. The list of permitted
for registration approval:5 food additives does not include all of the additives and colourants
used in the production of Nutraceutical goods. The registration
Application form A for registration process for Nutraceuticals in India involves complying with the
Self-attested declaration form license for manufacturing/ import regulations set by the Food Safety and Standards Authority of
license. India (FSSAI). Here is a general outline of the registration process:

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Determine the category: Identify the specific category of the Food Recall
Nutraceutical product based on its formulation and intended use. Food available for human consumption should meet the standards
Nutraceuticals can fall under various categories such as dietary of being wholesome, free from adulteration and contamination,
supplements, functional foods, functional beverages, or herbal suitably labelled and safe for consumption by people. Regulations
extracts. under the Act, or rules and regulations adopted thereunder, may
Formulate the product: Develop the formulation of the be taken against the relevant FBO for violating the laws in this
Nutraceutical product, ensuring it meets the necessary safety regard. Food recalls serve as an efficient approach to eliminate or
and quality standards. This may involve sourcing appropriate rectify non-compliant food products from the market under the
ingredients, conducting research and development, and ensuring supervision of regulatory authorities. They involve the proactive
compliance with applicable regulations and guidelines. removal of food items from all stages of the food supply chain,
including those already in consumers' possession, in cases where
Obtain manufacturing license: If you plan to manufacture the there is a potential risk to public health or when they don't
Nutraceutical product, obtain a manufacturing license from adhere to the conditions established in the relevant laws, rules,
the State Licensing Authority or Central Licensing Authority, or regulations. A food recall is generally thought to be in the best
depending on the scale of production. The license ensures interests of the industry, the government, and, most importantly,
compliance with Good Manufacturing Practices (GMP) and the consumers. Its main goal is to ensure consumer safety.
other manufacturing standards.
Recalls offer a more efficient and prompt means of safeguarding
Conduct safety and efficacy assessment: Before seeking consumers, especially in cases where a widely distributed
registration, conduct appropriate safety and efficacy assessments product is involved, compared to formal administrative or civil
of the Nutraceutical product. This may involve conducting actions. This mechanism ensures that necessary actions are taken
toxicological studies, clinical trials, or gathering scientific swiftly to address potential risks or non-compliance, thereby
evidence to support the product's claims. providing enhanced protection for consumers. Manufacturers
Submit the application: Prepare the registration application in
accordance with the requirements specified by the FSSAI. The
application should include details such as product composition,
manufacturing process, labeling information, scientific data, and
safety assessments.
Submit the product samples: Along with the application,
provide representative samples of the Nutraceutical product to
the designated laboratory for testing. The samples will undergo
analysis to ensure compliance with quality and safety standards.
Review and approval: The FSSAI will review the application
and supporting documents, including the test reports. If the
application meets all the requirements, the FSSAI will grant
registration for the Nutraceutical product. The registration may
include specific conditions, labelling requirements, or limitations,
depending on the product category.
Compliance with labelling regulations: Once the registration is
obtained, ensure that the Nutraceutical product complies with
the labelling regulations specified by the FSSAI. This includes
providing accurate and comprehensive information on the
product label, such as ingredients, nutritional content, allergens,
and any specific claims or warnings.
It is important to note that the registration process and
requirements may vary depending on the specific category of
the Nutraceutical product. It is advisable to consult the FSSAI
website and seek professional guidance to ensure compliance
with the latest regulations and guidelines during the registration
process. The process is shown in Figure 1. Figure 1: Registration Process for nutraceuticals in India.

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examining product samples, conducting laboratory tests, and

evaluating the potential risks associated with the product.
Notification and Communication: The responsible party, which
can be the manufacturer, distributor, or retailer, should promptly
notify the relevant regulatory authority about the issue. They
should also establish effective communication channels to inform
consumers, retailers, and other stakeholders about the recall and
the associated risks. Clear and concise messaging is crucial to
ensure that the recall information reaches the intended recipients.
Product Retrieval: The next step is to retrieve the affected product
from the market, including distribution centers, retailers, and
potentially consumers' possession. The responsible party should
develop a plan for the efficient and comprehensive retrieval of
the recalled product. This may involve working closely with
distributors, retailers, and other supply chain partners to facilitate
the removal of the product from the market.
Disposal or Corrective Action: Once the recalled products are
retrieved, proper disposal methods are implemented to ensure
they are safely and securely disposed of to prevent any further
risk to public health. In some cases, corrective actions may be
taken, such as reworking or reprocessing the product to address
the identified issues.
Evaluation and Review: After the recall process is completed,
a thorough evaluation and review of the entire process should
be conducted. This includes assessing the effectiveness of the
Figure 2: Food Recall plan.
recall, identifying any areas for improvement, and implementing
and distributors bear the responsibility of proactively initiating corrective measures to prevent similar issues in the future.
a recall whenever necessary to fulfil their obligation of ensuring
It is important to note that the specific procedures and
public health and safety. This obligation applies to products that
requirements for initiating a food recall may vary by jurisdiction
may pose risks such as injury, deception, or any other form of and the nature of the issue. The responsible party should closely
defect. follow the guidelines and regulations provided by the relevant
The initiation of a food recall is an essential step in ensuring regulatory authority to ensure compliance and effective recall
consumer protection and maintaining the integrity of the management. Additionally, businesses may decide to start a
food supply chain. It demonstrates the commitment of food recall of goods in response to alerts from the Food and Drug
Administration or a state agency, in compliance with official
manufacturers, distributors, and regulatory authorities to
requests from the authority, or as directed by the regulatory
promptly address and rectify any potential issues that could
organisation. The process is shown in Figure 2.
compromise public health and safety. The initiation of a food
recall process involves several key steps and stakeholders. Here is CONCLUSION
a general outline of the process:
In conclusion, the nutraceuticals market in India has witnessed
Identification of the Issue: The first step is to identify a problem substantial growth in recent years, propelled by various factors
or issue with a food product that poses a potential risk to public including a growing awareness of health, higher disposable
health or violates food safety regulations. This can be done incomes, and evolving lifestyles. The nutraceuticals market in
through various means, including consumer complaints, routine India comprises diverse segments such as dietary supplements,
inspections, laboratory testing, or notifications from regulatory functional foods, functional beverages, and herbal extracts. The
authorities. nutraceutical business in India is governed by the Food Safety
and Standards Authority of India (FSSAI). It is in charge of
Investigation and Evaluation: Once the issue is identified, a setting standards, maintaining food safety, and managing the
thorough investigation is conducted to assess the nature and application of laws in this industry. The rules guarantee the
extent of the problem. This may involve gathering information, nutraceutical products' safety, quality, and labelling requirements.

602 Journal of Young Pharmacists, Vol 15, Issue 4, Oct-Dec, 2023

 Nori, et al.: Regulatory Landscape of Nutraceuticals

The registration process for nutraceuticals involves complying CONFLICT OF INTEREST

with the FSSAI regulations, which include product formulation,
The authors declare no conflict of interest.
obtaining manufacturing licenses, conducting safety and
efficacy assessments, and submitting the registration application REFERENCES
along with product samples for testing. Once the application 1. Patel K, Patel U, Vaghela K, Kanki N, Zaveri M, Movaliya V. Comparisons of registration
requirements of Nutraceuticals in Philippines, Tanzania, Cambodia and India. Int J
is reviewed and approved, the nutraceutical product can be Drug Reg Affairs. Published 2022;10(4):18-23. doi: 10.22270/ijdra.v10i4.546.
registered and marketed in India, subject to specific conditions 2. Chaturvedi S, Sharma PK, Bansal M. Role of Nutraceuticals in health promotion. Int J
Pharm Tech Res. 2011;3(1):442-8.
and labelling requirements. It is important for nutraceutical 3. Indian advantage: nutraceutical industry Dr R.B. Smarta CMD-interlink, vice
president-HADSA. Pharma Times; Published 2021;53(3).
companies to stay updated with the evolving regulatory
4. Sharma A, Kumar P, Sharma P, Shrivastava B. A comparative study of regulatory
landscape and comply with the latest guidelines and standards registration procedure of nutraceuticals in India, Canada and Australia. Int J Pharm
Qual Assur. 2013;4(4): 61-6:Article2.pdf.
to ensure consumer safety and trust. Professional guidance and 5. Gopal PNV, Kumar Lakshmi S, Anusha P, Nagarjuna Reddy D, Nagabhushanam
adherence to Good Manufacturing Practices (GMP) are essential MV. Comparison of registration process of Nutraceuticals and herbal supplements
in India, US and Europe, an international journal of advances in pharmaceutical
for successful product registration and market entry. As the sciences [internet]. 2014;5(4):2271-80. Available from: http://www.pharmanest.net
/comparison-ofregistration-process-of-Nutraceuticals-and-herbalsupplements-in-
Indian population continues to prioritize health and wellness, india-us-and-europe-465.html [cited 2014 August].
6. Chaturvedi S, et al. Role of Nutraceuticals in health promotion. Int J PharmTech Res.
the nutraceutical market is expected to witness further growth 2011;3(1):442-8.
and offer opportunities for both domestic and international 7. Brower V. Nutraceuticals: poised for a healthy slice of the healthcare market? Nat
Biotechnol. 1998;16(8):728-31. doi: 10.1038/nbt0898-728, PMID 9702769.
players. Continuous research and development, innovation, and 8. Kessler RC, Davis RB, Foster DF, Van Rompay MI, Walters EE, Wilkey SA, et al. Long
term trends in the use of complementary and alternative medical therapies in the
compliance with regulatory requirements will be key factors for United States. Ann Intern Med. 2001;135(4):262-8. doi: 10.7326/0003-4819-135-4-
success in this dynamic and evolving industry. 200108210-00011, PMID 11511141.
9. Ohama H, Ikeda H, Moriyama H. Health foods and Foods with health claims in Japan.
Toxicology. 2006;221(1):95-111. doi: 10.1016/j.tox.2006.01.015, PMID 16488527.
CONCLUSION 10. Hathcock J. Dietary supplements: how they are used and regulated. J Nutr. 2001;
131(3s):1114S-7S. doi: 10.1093/jn/131.3.1114S, PMID 11238828.
The authors are thankful to Shri Vishnu College of Pharmacy for 11. Allen LV. Nutritional products. In: Covington TR, Berardi RR, Young LL, et al i>., editors.
Handbook of nonprescription drugs. Washington, DC: American Pharmaceutical
providing necessary facilities. Association; 1997.

Cite this article: Nori LP, Sowmya P, Madhusree T, Raju KV. Nutraceuticals: Regulatory Landscape and Market Dynamics in The Indian Scenario. J Young Pharm.
2023;15(4):595-603.

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