India: Law Of Nutritional & Supplemental Food Products In India - The Conflict: Food Or Drug?

Last Updated: 12 February 2013
Article by Vijay Pal Dalmia, Partner

Article by Vijay Pal Dalmia, Advocate Delhi High Court and Supreme Court of India
Partner, Vaish Associates Advocates, New Delhi, India,

One of the potential threats for manufacturing and sale of food/health supplements such as "Dietary food supplement", "Food supplements", "Nutritional supplements", "Health supplements", is its categorization in the category of "Food" or "Drugs", as there is a very thin line between "drugs/ medicines" and "nutritional supplements". Practically all ingredients of a nutritional supplement, known through different nomenclatures, include the ingredients which may fall into the category of drugs as well as food supplements.

Present Indian law for foods is contained in the (Indian) FOOD SAFETY AND STANDARDS ACT, 2006, (FSS Act ) under which an embargo has been placed under Section 22 of the FSS Act stating that no person shall manufacture, distribute, sell or import any novel food, genetically modified articles of food, irradiated food, organic foods, foods for special dietary uses, functional foods, neutraceuticals, health supplements, proprietary foods and such other articles of food which the Central Government may notify, except in accordance with FSS Act or rules made there under. Prior to the FSS Act, a manufacturer had to comply with the Prevention of Food Adulteration Act,1954 (PFAA) and Rules framed there under.

The determination of the categorization of "Dietary food supplement", "Food supplements", "Nutritional supplements", "Health supplements" becomes important to identify whether a particular manufacturer or seller of the said products would become eligible for mandatory regularization under the FSS Act, as the new Rules, i.e.1 FOOD SAFETY AND STANDARDS (LICENSING AND REGISTRATION OF FOOD BUSINESSES) REGULATIONS, 2011 ( FSS Regulations) formulated under the FSS Act also mandate for compulsory registration by any food business operator with the Foods Safety and Standards Authority of India (FSSAI), since the FSSAI has been created for laying down scientific standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption.

It is significant to note that various products, claiming to contain high amounts of vitamins and minerals, are being sold in the Indian market as health/food supplements. At the same time, multivitamin tablets and products containing other nutrients are being sold as drugs, with requisite licensing from the Drug authorities. This confusion, or if it can be said that the liberty taken by the manufacturers in the garb of food safety laws to avoid rigours of drug laws acquire importance, as the manufacturers and traders of food supplements may be running the risk of prosecution in case of incorrect categorization. There is a thin line of distinction between food/health supplement and drugs, particularly in a case where the contents and quantum of nutritional value and vitamins are specifically mentioned for various commercial reasons, making the categorisation highly subjective. There is also no judicial unanimity in this regard. There is no specific statutory or judicial yardstick available for being decisive on this aspect. Accordingly, the categorization of health and nutritional supplements as "food supplement" or "drug" would depend on the analysis of the ingredients/composition of the particular supplement as well as subjectivity of the authorities.

A dietary supplement may be defined as a product taken by mouth that contains a dietary ingredient and / or a new dietary ingredient intended to supplement the diet. The dietary ingredients in these products may include: vitamins minerals herbs or other botanicals amino acids and substances such as enzymes organ tissues glandular and metabolites.

However, despite the legislative mandate, no rules under Section 22 of the FSS Act have been notified till date. The explanation of Section 22 of the FSS Act defines "foods for special dietary uses or functional foods or neutraceuticals or health supplements" in the following terms:

(a) foods which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition or specific diseases and disorders and which are presented as such, wherein the composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist, and may contain one or more of the following ingredients, namely:-

(i) plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or hydro alcoholic extract, single or in combination;

(ii) minerals or vitamins or proteins or metals or their compounds or amino acids (in amounts not exceeding the Recommended Daily Allowance for Indians) or enzymes (within permissible limits);

(iii) substances from animal origin;

(iv) a dietary substance for use by human beings to supplement the diet by increasing the total dietary intake; and


(i) a product that is labelled as a "Food for special dietary uses or functional foods or neutraceuticals or health supplements or similar such foods" which is not represented for use as a conventional food and whereby such products may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly and other dosage forms but not parenterals, and are meant for oral administration;

(ii) such product does not include a drug as defined in clause (b) and ayurvedic, sidha and unani drugs as defined in clauses (a) and (h) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rules made there under;

(iii) does not claim to cure or mitigate any specific disease, disorder or condition (except for certain health benefit or such promotion claims) as may be permitted by the regulations made under this Act;

(iv) does not include a narcotic drug or a psychotropic substance as defined in the Schedule of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) and rules made there under and substances listed in Schedules E and EI of the Drugs and Cosmetics Rules, 1945;

From the above it is clear that under the present Indian law, no person can manufacture, distribute, sell or import any foods for special dietary uses or functional foods or neutraceuticals or health supplements, unless in accordance with the provisions of the FSS Act or FSS Regulations made there under.

It is pertinent to point out that the draft regulations in this regard have been prepared by the Ministry of Health and Family Welfare in exercise of power conferred under Section 22 and 92 of the FSS Act. These draft regulations have elaborately defined the word "health supplements" as under:

'Health Supplements' can be explained as foods which are intended to supplement the normal diet of a person, and which are concentrated sources of one or more nutrients, like minerals, vitamins, proteins, metals or their compounds, amino acids or enzymes, other dietary substances, plants or botanicals , substances from animal origin or other similar substances with known and established nutritional or physiological effect, and which are presented as such, wherein the composition of these foodstuffs differ significantly from the composition of ordinary foods of comparable nature, and are offered alone or in combination, but are not drugs as per the Drugs and Cosmetics Act 1940 and Rules made there under.

The said regulations providing the standards for novel food, foods for special dietary uses, functional foods, neutraceuticals, health supplements, proprietary foods and such other articles of food have yet not been notified. Therefore, under the FSS Act, the position of nutrition and supplements products is still vague and ambiguous.

It may be noted that Section 98 of the FSS Act relates to transitory provisions for food standards and states as under:

"Notwithstanding the repeal of the enactment and Orders specified in the Second Schedule, the standards, safety requirements and other provisions of the Act and the rules and regulations made there under and Orders listed in that Schedule shall continue to be in force and operate till new standards are specified under this Act or rules and regulations made there under......."

It can be argued that due to Section 98 of the FSS Act, and in absence of notified regulations, Rule 37A of The Prevention of Food Adulteration Rules, 1955 (hereinafter referred as "PFA Rules"), though repealed by the FSS Act, would remain in force and be applicable on manufacture of health supplements food since clause 1 of Rule 37A defines "Proprietary food" as a food which has not been standardized under the PFA Rules, as in the case of health and nutritional supplements which are not defined under the Prevention of Food Adulteration Act, 1954.

Rule 37A of the PFA Rules provides as under:


(1) Proprietary food means a food which has not been standardized under the Prevention of Food Adulteration Rules, 1955.

(2) In addition to the provisions including labeling requirements as prescribed under these rules, all proprietary foods shall also conform to the following requirements:-

(a) the manufacturer of proprietary products shall obtain separate licence for manufacture of each proprietary food products;

Provided that Halwais manufacturing traditional foods like Indian traditional snacks and sweets shall obtain a composite licence;

(b) the name of the food and/or category under which it falls in these rules shall be mentioned on the label;

(c) tobacco and nicotine shall not be used as ingredients in the manufacture of proprietary food products;

(d) where any food contains any allergenic and / or hypersensitive ingredients as identified under the rules, or any ingredient originating from an allergenic and / or hypersensitive ingredients does not specify the allergenic ingredients / hypersensitive ingredients, such food shall the label declaration as provided under clause (24) of subrule (zzz) of rule 42.

(e) the proprietary food product shall not contain food additives except as provided in the rules for that food and / or category of food.".

From the perusal of above Rule 37A, it is clear that any person manufacturing a product as proprietary food under the PFA Rules has to mandatorily comply with the above requirements.

In the case of Glaxo India Ltd. Vs. State Of Assam And Ors2, the Gauhati High Court held that wherein after considering the composition and ingredients for preparation of both GLUCON-C and GLUCON-D, it was held that these products as such, cannot at all be called an article of 'food under a misbranded name' and without any hesitation one can come to the conclusion to call these products as 'proprietary food'. It was also held that:

"Since 'proprietary food' cannot be the subject-matter of standards laid down in Appendix 'B', the question of non-conformity of the product 'GLUCON-C and GLUCON-D with standards prescribed under Appendix 'B' under Rule 37A, cannot be considered at all for declaring this articles of food as misbranded."

In the case of Hindustan Lever v. Food Inspector3, the Supreme Court of India has held that the instant dairy whitener is an article for which no standards has been laid and hence the standard for skimmed milk powder cannot be applied to instant dairy whitener as it contained only partly skimmed milk powder with other ingredients. Therefore the standards of such supplements would be determined based on the facts and circumstances of each case.

In the case of State of Maharashtra vs Pravin Krishnadas Shah4 it was held that the said supplements cannot be considered as drugs as:

"It is common knowledge that proteins are a body building substance - a nutrition, while a medicine is a therapeutic substance - essentially connected with healing. In absence of evidence on all aspects it will be difficult to term proteins as a 'medicine'."

The definition of "Drugs" has been elaborated under clause (b) and ayurvedic, sidha and unani drugs as defined in clauses (a) and (h) of section 3 of the Drugs and Cosmetics Act, 1940 (hereinafter referred as "the DCA, 1940") and rules made there under.

Section 3 (b) of the DCA, 1940 provides that "drug" includes:

(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;

(ii) such substances (other than food) intended to affect the structure or any function of human body or intended to be used for the destruction of (vermin) or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;

(iii) all substances intended for use as components of a drug including empty gelatin capsules; and

(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board ;

From the bare perusal of above section, it is clear that health or nutritional supplements may be categorized as drugs, because of the very wide definition of drug as provided in the DCA, 1940. Any "foods for special dietary uses or functional foods or neutraceuticals or health supplements" which falls within the definition of "drugs" under the DCA, 1940, has to be excluded from the applicability of the FSS Act.

For understanding the issue, reliance can also be laid on the verdict of the Kerala High Court in Cadila Pharmaceuticals Ltd. vs. State Of Kerala And Ors.

The High Court in the above case held EC 350 (Vitamin E and Vitamin C capsules) and Cecure (Multi-Vitamin Capsules) manufactured by the petitioner and sold in the market through medical shops as "Dietary Supplements" to fall within the definition of "drug" requiring licence under the Drugs and Cosmetics Act, 1940.

It was also held in the above case that "the definition of 'drug' in the Act clearly specifies that all, substances intended to be used for mitigation or prevention of any disease or disorder in human beings is a drug and further all substances intended for use as components of a drug including empty gelatin capsules is a drug."

In the case of Dr. Reddy's Laboratories Limited vs State Of Kerala, the test for determining "whether a particular supplement should be treated as a medicine?" was laid down as under:

"The word medicine means, any substance/chemical which when used in a disease will lead to cure or improvement.

The dietary supplement means any substance (usually a food item/ingredient) which helps in maintenance of health.

The clear distinction between health and disease is not there. What is healthy for a particular person/sex/ethnic group is a disease for someone else (for example being slim is healthy for a model but is a sign of malnutrition for a pregnant woman or for doctors). Since the distinction between disease and health itself is not clear, dietary supplement versus medicine is also not clear in many circumstances. In some way, we need to draw a distinction for various reasons (for rigorous pre-clinical and post marketing testing and for taxation purpose).

If GLA-120 is used to treat diabetic neuropathy then it should be considered a medicine. If for some reason it is used in normal healthy people (which it is not supposed to) as a tonic to improve the general well being, then it is a dietary supplement. If GLA-120 is a medicine then question still remains whether it has undergone the same rigorous stage I (testing in healthy volunteers), stage II (testing in diseased people) and stage III (randomized trials) clinical trials and whether its entire side effect profile and harmful effects are known in large group of people. If it is a dietary supplement it may not require such rigorous clinical testing and it may be available over the counter without doctors' prescription."

In an important case of The State of Bihar vs. Alkem Laboratories Limited, wherein the question whether certain products, which were in the nature of health supplements, would fall into the category of 'food' or 'drug' came before the Hon'ble High Court of Patna. The Court held that:

"Having heard both the parties and on a perusal of the report submitted by Director General of Health Services, Govt. of India, we are of the opinion that in the expert opinion as with regard to labelling of the drugs no material is available before this Court with regard to effect of the composition of such ingredients on the human body. If they are consumed as a 'food'. Of course, it is the general parlance that the ingredients generally would be tested on some animals for its ill-effects on the human body before its release in the open market.

The perusal of the report indicates the opinion is formed by the experts only on seeing the 'labelling' on the products. But there is no indication in the report with regard to the effects such products would cause on the human body. In the absence of such indication, we are of the opinion that it would be difficult to arrive at a conclusion whether it can be classified as a 'food' or 'drug'. But, however, in view of the controversy that arose in this case the Director General of Health Services, Govt. of India would take a fresh look into the matter by directing the experts to analyze the ingredients or components of each drug to know the effect of such drugs on the human body. In absence of such analysis, any one cannot come to the conclusion that whether it is a 'drug' or a 'food'.

Under the above circumstances, we are of the opinion that the matter can be referred back to the expert committee of the Drug Technical Advisory Board as provided under the Drugs and Cosmetics Act, 1940 and also under the provisions of the Prevention of Food Adulteration Act,1954 for analyzing the component or ingredients of each products and its effect on the human body if consumed as a food and come to the conclusion whether the products would fall under the classification of the Drugs and Cosmetics Act, 1940 or under the Prevention of Food Adulteration Act as 'food'."

It is very important to note that all of the above mentioned cited cases were decided before the FSS Act came into force. The present position would be governed under the provisions of the FSS Act. The confusion continues.



2 (2003) 1 GLR 407

3 2003(16)CriminalCC970

4 MANU/MH/0060/1984

5 AIR 2002 Ker 357

6 LPA No.865 of 2009

© 2013, Vaish Associates, Advocates,
All rights reserved with Vaish Associates, Advocates, 10, Hailey Road, Flat No. 5-7, New Delhi-110001, India.

The content of this article is intended to provide a general guide to the subject matter. Specialist professional advice should be sought about your specific circumstances. The views expressed in this article are solely of the authors of this article.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Vijay Pal Dalmia, Partner
In association with
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.