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REPORTABLE
IN THE SUPREME COURT OF INDIA
CIVIL APPELLATE JURISDICTION
CIVIL APPEAL NO. 5644 OF 2003
INDIAN SOAPS & TOILETRIES MAKERS
ASSOCIATION …. APPELLANT
Versus
OZAIR HUSAIN AND OTHERS .… RESPONDENTS
WITH
CIVIL APPEAL NO. 5645 OF 2003
UNION OF INDIA AND ANOTHER ….
APPELLANTS
Versus
OZAIR HUSAIN .…
RESPONDENT
J U D G M E N T
SUDHANSU JYOTI MUKHOPADHAYA, J.
These appeals have been preferred by the appellants
against the judgment dated 13th November, 2002 passed by
the Division Bench of the Delhi High Court
in a Public Interest
Litigation (Civil Writ Petition No.837 of 2001) whereby the High
Court held that
the consumer has the fundamental right to
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know whether the food products, cosmetics and drugs
available for human consumption are of non-vegetarian or
vegetarian origin and ordered as follows:
"In so far as cosmetics are concerned, the
same must be treated at par with
articles/packages of food for the purpose of
disclosure of their ingredients.
Till such time the requisite amendments
are carried out, we direct as under:-
(1) Where a cosmetic or a drug other than
life saving drug, as the case may be, contains
ingredients of non- vegetarian origin, the
package shall carry label bearing the following
symbol in red colour on the principal display
panel just close a proximity to name or brand
name of the drug or cosmetic:-
(2) Where a cosmetic or a drug other than
life saving drug, as the case may be, contains
ingredients wholly of vegetarian origin, the
package shall bear the following symbol in green
colour on the principal display panel just close in
proximity to name or brand name of the drug or
cosmetic:-
(3) Where a cosmetic or a drug other
than life saving drug has ingredients of
vegetarian of non- vegetarian origin, a
declaration shall be made in writing on the
package indicating the nature of the origin of the
product.
(4) The Director General of Health
Services/Drugs Controller General,
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Government of India, shall issue a list of Life
Saving Drugs within a period of two months.”
2. The Public Interest Litigation was filed by the respondent
claiming the right of a consumer of cosmetics, drugs and
articles of food to the full disclosure of ingredients of such
product whereby a clear indication as to its origin
(vegetarian/non-vegetarian) is made.
The High Court referring to the constitutional rights
guaranteed under Articles 19(1)(a), Articles 21 and 25 of the
Constitution of India held:
“…………..It seems to us that to enable a person
to practise the beliefs and opinions which he
holds, in a meaningful manner, it is essential for
him to receive the relevant information,
otherwise he maybe prevented from acting in
consonance with his beliefs and opinions. In case
a vegetarian consumer does not know the
ingredients of cosmetics, drugs or food products
which he/she wishes to buy, it will be difficult for
him or her to practise vegetarianism. In the
aforesaid context, freedom of expression
enshrined in Article 19(1)(a) can serve two broad
purposes – (1) it can help the consumer to
discover the truth about the composition of the
products, whether made of animals including
birds and fresh water or marine animals or eggs,
and (2) it can held him to fulfil his belief or
opinion in vegetarianism.”
“…..In this view of the matter, we have no
hesitation in holding that Article 21 grants
freedom to an individual to follow and to stick to
his opinions, and for pursuing such a course he
had right to receive information and also a right
to know the ingredients or the constituents of
cosmetics, drugs and food products.”
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“……In view of the aforesaid discussion, we
are of the view that it is the fundamental right of
the consumers to know whether the food
products, cosmetics and drugs are of nonvegetarian or vegetarian origin, as otherwise it
will violate their fundamental rights under Articles
19(1)(a), 21 and 25 of the Constitution.
Accordingly, we answer the main question in the
affirmative. Since there is a constitutionally
guaranteed right of the consumers to the full
disclosure of the ingredients of cosmetics, drugs
and articles of food, answers to remaining
questions (ii) and (iii) necessarily are required to
be answered in the affirmative. We, accordingly,
answer the questions (ii) and (iii) also in the
affirmative……”
“……In so far as food products are
concerned, adequate provisions have been made
for informing the consumers as to whether or not
the article of food is vegetarian or nonvegetarian. As regards drugs and cosmetics,
necessary amendments have not been made in
the relevant statutes. In so far as life saving drug
is concerned, there is a view point that the
information: whether or not it is derived or
manufactured, wholly or partly, from an animal,
should not be disclosed since it is meant to fight
disease and save life. In other words, a patient,
who is suffering from serious ailment, which can
be fatal if a life saving drug is not administered to
him, need not be informed in his own interest as
to whether or not the drug contains part of any
animal as it is conductive to preservation of life
and, therefore, in tune with Article 21 of the
Constitution, this also means that he should not
have a choice in the matter of administering life
saving drug to him. In many cases patients are
unconscious and they have to be put on life
saving drugs. In any event they cannot exercise
an informed choice in the matter of selection of
drugs. In the circumstances, therefore, the
aforesaid view must prevail in case of life saving
drugs. This limited exception will apply only to life
saving drugs. It needs to be clarified that all
drugs do not qualify for being treated as life
saving drugs. Drugs which are not life saving
drugs must stand at part with the food products
and must disclose whether or not they are made
of animal, whether in whole or in part.
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"In so far as cosmetics are concerned, the
same must be treated at par with
articles/packages of food for the purpose of
disclosure of their ingredients.”
3. The appellant Union of India is afraid of serious paradox
in so far as drugs are concerned. According to the learned
senior counsel, it is not possible to distinguish as to which drug
is a ‘Life Saving Drug’ or otherwise; under a given
circumstance and condition of patient, a drug which ordinarily
may not be treated as a ‘Life Saving Drug’, can be used as a
Life Saving Drug. In some other case it may be general. Thus,
it is not possible to demarcate the drugs as life saving or
otherwise. Therefore, the direction issued by the High Court to
the extent it requires Union of India to prepare a list of Life
Saving Drugs would neither be appropriate nor proper,
particularly when there is no definition of ‘Life Saving Drug’ in
pharmacology of the modern system of medicines.
4. It was further contended that every drug is considered to
be useful in either saving or prolong the life by curing,
mitigating or preventing diseases. Given that every disease has
the eventuality of taking life if not properly treated in time, the
identification of ‘Life Saving Drug’ will depend upon
identification of different situations when they are required.
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5. Further, according to the learned counsel for the Union of
India, the direction of the High Court for affixing Red Label
which is symbolic of danger on drugs and cosmetics is
inappropriate particularly when a Cosmetics Sectional
Committee had recommended the use of ‘Brown’ colour for
labelling certain cosmetic products. He also placed reliance on
the report submitted by the ‘Drug Technical Advisory
Committee’ constituted under Section 5 of the Drugs and
Cosmetics Act wherein the reason was shown for not providing
any identification as to ‘ingredient of non-vegetarian origin’.
6. Learned counsel appearing on behalf of the appellantIndian Soaps & Toiletries Makers Association (hereinafter
referred to as the ‘Association’) submitted that it is neither
practicable nor desirable to give any identification as to
ingredients of ‘vegetarian’ or ‘non-vegetarian’ origin. It has no
relevancy as the use of cosmetics has nothing to do with the
vegetarian or non- vegetarian origin ingredients; they are not
‘food products’ and are not meant for ingestion. It was
submitted that it is difficult to identify the origin of nonvegetarian ingredients, as it is very difficult to know the basic
source from which such ingredient is derived.
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7. The following arguments were also advanced on behalf of
the Association:
(a)Unlike food items, generally cosmetic items are
not ingestible. Every single dictionary definition
of words “vegetarian” “non-vegetarian” relate
to food or the act of eating. Therefore, the
sentimental feeling that is brought upon by the
consumers for any edible items are not
applicable to cosmetic items. The rationale, i.e.
emotional, religious, cultural, sentimental,
health values which necessitate different
treatment in terms of vegetarian and nonvegetarian for food items coming from animal
and non-animal sources respectively does not
hold good for cosmetic items (i) on account of
its external application and (ii) on account of
long held and general awareness amongst
consumers about cosmetic composition.
(b)Unlike the food industry where the processing of
food takes place near to the primary produce or
a step away from the primary produce center
and not many intermediary stages are involved
before the final food item is packed for
consumption, cosmetic industry is far removed
from the stage of raw material sources.
Cosmetics are manufactured from a significantly
large number of raw materials which in turn
contain composite ingredients while food items
are manufactured generally from 4 to 5 basic
raw materials.
(c) Unlike food items where the analysis
mechanism is reasonably established through
PFA Act ad Rules, the analysis of cosmetic
products by its sheer complexity is difficult,
which difficulty gets compounded on account of
non-availability of technology, large number of
ingredients coming in from different sources. In
the absence of such technology being available
the requirement of indicating symbols on labels
would be impractical and would lead to chaos
and confusion in as much as cosmetics with
animal origin ingredients would carry
vegetarian symbol or vice versa, and thus it will
defeat the very purpose for which such
requirement is intended.
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(d)Unlike food products which are normally
manufactured and consumed in India, barring a
few exceptions, the cosmetic industry competes
with international products both in terms of
import as well as exports and consequently,
requiring the industry to put such a label
without any technology being available for
making such distinction would not only add
enormous cost on the industry but also place
the Petitioners members at disadvantage in
competing with international cosmetic products.
Such labelling without any technology for
analysis is also likely to be challenged against
the Petitioner’s members who instead of
promoting and encouraging exports from India
would be left with fighting legal battles at
enormous cost and at the cost of foreign
exchange.
8. According to the appellant-Association, the High Court
failed to appreciate that cosmetic formulation is complex in
nature as compared to drugs or the food products. The
appellant-Association relied on following facts to justify their
finding:
(1) There are as many as 66 dosage forms in
cosmetic formulations as listed in one of
the standard reference books- The
Chemistry & Manufacture of Cosmetics by
Maison deNavaree, Allured Publishing.
(2) Schedule S of Drugs & Cosmetics Act
recognizes 29 of such types of cosmetics.
(3) Each type of formulation has wide choice
of 12,000 ingredients approved by CTFA
or INCI directory of ingredients and are
safe for use in cosmetic products. Ref.:
CTFA on-line web site.
(4) In fact, some of the INCI ingredients are
mixture of ingredients in various
proportions of similar compounds. For
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example, commonly used CARBOMER is a
homopolymer of acrylic acid cross linked
with allyl ether of pentaerythritol, allyl
ether of sucrose or allyl ether of
propylene. It has 7 different technical
names based on different grades, 32
trade names and 7 trade name mixtures.
(5) Mostly a perfume is component of
cosmetic preparation. The perfumes are
proprietary formula by itself and are
mixture of several ingredients. Each
ingredient of perfume could be synthetic,
natural or animal in origin. Example –
Musk perfume is trade secret composition.
It may contain any number of ingredients
coming from any source as synthetic,
natural or animal origin. Generally
perfume contains 10-100 different
ingredients.
(6) All of these ingredients are purified
several times to reach the acceptable
form as required by INCI requirements. At
this stage it is at least 4th or 10th step of
purification, wherein original starting
material can not be traced back to even
ppb level. Example – Fatty acid based
surfactants from plant origin or purely
synthetic or animal origin.
(7) In case of food and drug related formulae,
there is list of limited excipients or
additives. In case of drug formulae,
mostly the excipients are only a few and
are published monographs in official
pharmacopoeia. In case of food, the
formulae are simple and contain very few
ingredients being declared on the pack.
So the origin is very easy to verify.
(8) Cosmetic formulae are far more complex
to drug formulae. The source of thousands
of ingredients being used in multiples of
combination in the cosmetic formulae,
make the task extremely difficult to check
and certify the origin of ingredients used.
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9. It was also contended that the power of determination of
labelling requirements including their contents is vested with
the Union of India’s authorities such as the Drug Technical
Advisory Board. In such case the High court ought not to have
given a finding to provide certain mark on the labelling of the
drugs and cosmetics based on vegetarian or non-vegetarian
origin.
10. Learned counsel appearing on behalf of the respondent
submitted that almost 60% of the population in India is
vegetarian, over 50% of it is illiterate and over 90% public
cannot read English. The Public Interest Litigation for disclosure
of the ingredients of the products was filed to safeguard the
interest of such innocent consumers and to ensure that such
products bear an easily recognizable symbol to know whether
it has any animal ingredient. The consumers have a right of
informed choice between the products made or derived from
vegetarian and those made or derived from non-vegetarian
ingredients.
11. The questions involved in this case are:
(i) Whether under Article 226 of the Constitution of
India the High Court has jurisdiction to direct the
manufacturers of drugs and cosmetics to display a
particular symbol in their packages to identify the
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ingredients of ‘ non- vegetarian’ or ‘ vegetarian’ origin;
and
(ii) Whether it is practicable and desirable to display
any identification as to the origin of the non-vegetarian
ingredients in the packages of drugs and cosmetics.
12. Before discussing the relevant provisions of the Drugs
and Cosmetics Act, 1940 and the Rules framed thereunder, it is
relevant to notice that with a view to prevent adulteration of
food stuff and bringing uniformity of laws in the country, the
Prevention of Food Adulteration Act, 1954 was enacted. Later
on when it was felt that the “consumer of food products”
should know whether any article of food contains whole or any
part of animal including birds, fresh water or marine animals or
eggs or product of any animal origin, the Government of India
by notification dated 4th April, 2001 enacted the Prevention of
Food Adulteration (Fourth Amendment) Rules, 2001 amending
Rule 32 and Rule 42 of the Prevention of Food Adulteration
Rules, 1955 and introduced symbol and colour code of
vegetarian and non-vegetarian food products. Under clause (b)
of amended Rule 32 of the Prevention of Food Adulteration
Rules, 1955, it was made compulsory to make declaration
whether article of food contains any non-vegetarian ingredients
by a symbol and colour code so stipulated for the said purpose,
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to indicate that the product is a non-vegetarian food. The
symbol of non-vegetarian food on every food product package
was introduced by inserting clause (16) of sub-rule (ZZZ) of
Rule 42 of the Prevention of Food Adulteration (Fourth
Amendment) Rules, 2001. The amendment came into effect
from 7th March, 2001.
But no such provision has been made to indicate whether
any ingredient of any drug or cosmetics is of non-vegetarian
origin.
13. “The Drugs and Cosmetics Act, 1940” was introduced to
regulate the import, manufacture, distribution and sale of
drugs and cosmetics including its package. “Drug” as defined
in Section 3(b) of the Drugs and Cosmetics Act, 1940 reads as
follows:
“3(b) “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
6(vermin) or insects which cause
disease in human beings or animals, as
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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 gelatine capsules; and
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(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 ;
‘Cosmetic’ is defined in Section 3(aaa):
“3(aaa) “cosmetic” means any article
intended to be rubbed, poured,
sprinkled or sprayed on, or
introduced into, or otherwise
applied to, the human body or any
part thereof for cleansing,
beautifying, promoting
attractiveness, or altering the
appearance, and includes any
article intended for use as a
component of cosmetic.”
14. Under Section 5 of the Drugs and Cosmetics Act, 1940 a
“Drugs Technical Advisory Board” is to be constituted to advise
the Central Government and the State Governments on
technical matters arising out of the administration of the Act
and to carry out other functions assigned to it by the Act. The
Board consists of the Director General of Health Services; the
Drugs Controller of India; the Director of the Central Drugs
Laboratory; the Director of Central Research Institute; the
Director of Indian Veterinary Research Institute, the President
of the Medical Council of India; the President of Pharmacy
Council of India; etc.
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The Central Government is also required to establish a
‘Central Drugs Laboratory’ under the control of a Director
under Section 6 ‘for analysis and test of samples of drugs’.
Under Section 7, the Drugs Consultative Committee is
constituted to advise the Central Government, the State
Governments and the Drugs Advisory Board on any matter
tending to secure uniformity throughout India in the
administration of the Act.
Under Section 8 standards of quality in relation to drugs
and cosmetics have been prescribed. Chapter III deals with the
definition of ‘misbranded drugs’; ‘adulterated drugs’; ‘spurious
drugs’; ‘misbranded cosmetics’; ‘spurious cosmetics’ etc.
Under Section 16, it is mandated that the quality of a
drug should comply with the standard as set out in the Second
Schedule. Similarly, the quality of a cosmetic should comply
with such standard as may be prescribed by the Central
Government.
The Act deals with disclosure of the name of the
manufacturer of a drug, cosmetic and its agent under Section
18A. The Central Government is also empowered under Section
26A to prohibit manufacture, etc., of drug and cosmetic in
public interest. The conditions to be observed in the packing
in bottles, packages, and other containers of drugs or
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cosmetics including regulating the mode of labelling of packed
drugs or cosmetics prescribed by the Central Government by
framing a Rule under Section 33 which reads as follows:
“33.Power of Central Government to make rules. —(1) The
Central Government may after consultation with, or on the
recommendation of, the Board and after previous publication by
notification in the Official Gazette, make rules for the purposes
of giving effect to the provisions of this chapter:
Provided that consultation with the Board may be dispensed
with if the Central Government is of opinion that circumstances
have arisen which render it necessary to make rules without such
consultation, but in such a case the Board shall be consulted
within six months of making of the rules and the Central
Government shall take into consideration any suggestions which
the Board may make in relation to the amendment of the said
rules.
(2) Without prejudice to the generality of the foregoing power,
such rules may—
xxx xxx xxx
xxx xxx xxx
(i) prescribe the conditions to be observed in the packing in
bottles, packages, and other containers of drugs or cosmetics,
including the use of packing material which comes into direct
contact with the drugs]and prohibit the sale, stocking or
exhibition for sale, or distribution of drugs or cosmetics packed
in contravention of such conditions;
(j) regulate the mode of labelling packed drugs or cosmetics,
and prescribe the matter which shall or shall not be included in
such labels;”
15. Part XV of the Drugs and Cosmetics Rules, 1945 relates to
labelling, packing and standards of cosmetics. The list of
ingredients, present in concentration of more than one per cent
is required to be listed in the descending order of weight or
volume under sub-rule (7) of Rule 148.
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Rule 149A is a special provision relating to toothpaste
containing fluoride whereunder it is mandatory to mention the
content of fluoride on the tube and the carton apart from the
date of expiry.
Rule 97 relates to ‘labelling of medicines’ :
“97. Labelling of medicines (1) The
container of a medicine for internal use
shall—
(a) if it contains a substance specified in
Schedule G, be labelled with the words
‘Caution: it is dangerous to take this
preparation except under medical
supervision’ – conspicuously printed and
surrounded by a line within which there
shall be no other words;
(b) if it contains a substance specified in
Schedule H be labelled with the symbol Rx
and conspicuously displayed on the left top
corner of the label and be also labelled
with the following words:
Schedule H drugWarning: To be sold by
retail on the prescription of a Registered
Medical Practitioner only’;
(c) if it contains a substance specified in
Schedule H, and comes within the purview of
the [Narcotic Drugs and Psychotropic
Substances Act, 1985 (61 of 1985)] be
labelled with the symbol NRx which shall be
in red and conspicuously displayed on the
left top corner of the label, and be also
labelled with the following words:
Schedule H drug “Warning: To be sold by
retail on the prescription of a Registered
Medical Practitioner only’;
(d) if it contains a substance specified in
Schedule X, be labelled with the symbol XRx
which shall be in red conspicuously
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displayed on the left top corner of the
label and be also labelled with the words :
Schedule X drug “Warning: To be sold by
retail on the prescription of a Registered
Medical Practitioner only’;
(2) The container of a embrocation,
liniment, lotion, ointment, antiseptic
cream, liquid antiseptic or other liquid
medicine for external application shall be
labelled with the word in capital ‘For
External use only’.
(3)The container of a medicine made up
ready only for treatment of an animal shall
be labelled conspicuously with the words
‘Not for human use; for animal treatment
only’ and shall bear a symbol depicting the
head of a domestic animal.
(4) The container of a medicine prepared
for treatment of human ailments shall if
the medicine contains industrial
methyllated spirit, indicate this fact on
the label and be labelled with the words :
“For External Use only”.
(5) Substances specified in Schedule X in
bulk form shall bear a label wherein they
symbol as specified in subrule (1) shall
be given conspicuously in red letters.”
Whereas Rule 105 relates to packing of drugs, including
sizes meant for retail sale as prescribed in ‘Schedule P’. For
other drugs, a separate packing has been prescribed under
Rule 105A read with ‘Schedule X’.
16. The Drugs and Cosmetics Act, 1940 or the rules
framed thereunder do not mandate mentioning or
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displaying symbol of ingredients of non-vegetarian or
vegetarian origin. The manufacturer or others are not
required to mention ‘vegetarian’ or ‘non-vegetarian’ on
the label of drugs or cosmetics.
The Central Government is vested with the power under
the Drugs and Cosmetics Rules, 1945 to amend the ‘label of
the drugs and cosmetics’ in consultation with the Drugs
Technical Advisory Board. Without fruitful consultation with the
Drugs Technical Advisory Board, no amendment can be made
or suggested to change the label of the drugs and cosmetics.
17. Earlier a proposal was made by certain persons to amend
‘the Drugs and Cosmetics Rules, 1945’ so as to mention the
words “vegetarian” and “non-vegetarian” on the labels of the
drugs and cosmetics. After fruitful deliberations, the Drugs
Technical Advisory Board in its 48th Meeting held on 8th July,
1999 rejected the proposal as quoted hereunder:
“AGENDA ITEM NO.3
PROPOSAL TO AMEND DRUG & COSMETIC RULE
1945 TO REQUIRE MENTION OF WORDS
V(VEGITAIAN) AND NV(NON VEGITARIAN) ON
LABELS OF DRUGS/COSMETICS
Ministry of Social Justice and
Empowerment nominated Shri Devdas
Chhotray, Joint Secretary, Ministry of Food
Processing and Shri S.R. Khanna, representative
from an NGO, VOICE for acquainting the Board
Members with their views on this subject. Sh.
Chhotray, explained regarding his Ministry’s
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concern about the killing of animals and
consumer’s right for information. He stated that
some consumers may like to avoid use of any
product containing material from animal source
if they have recourse to such information and
this need of consumer requires to be respected.
It was, therefore, proposed that the provision
for labelling V and NV on every food/drug
product depending on its vegetarian or non
vegetarian aspects may be introduced in the
Drugs & Cosmetics Rules.
Dr. S.R. Khanna, also, in detail stressed
upon consumers rights to such information and
desired a mandatory provision to indicate the
source of drug in terms of V and NV.
The Chairman explained that while
respecting the consumers rights to information
the issue of V & NV markings need to be
examined in wider perspectives of medical
treatment an critical importance of certain
drugs products like vaccines, harmones, Biotech
products etc. which are of life saving nature and
could be traced to animal origin. (Unlike food,
drugs are not taken by choice or for the purpose
of gratification). He, however, suggested that in
the context of general understanding of
vegetarianism such drugs where macroscopic
portion of animal tissues like animal blood, liver
extract etc. are present in oral preparations
may be considered by the Board for marking NV
on the label of such drugs.
1. Prof. Jindal opined that the drugs may be
labelled to indicate their source i.e. synthetic
source, Bio Source and animal source. This
suggestion was, however, not found practicable.
2. Prof. Kokato and Mrs. Muthuswamy
representatives of ICMR felt that what may be
appropriate in case of food may not necessarily
be appropriate in case of drugs which are
prescribed for relief from disease conditions and
many a times in life threatening situation. To
introduce the concept of Vegetarian and Non
Vegetarian by marking V or NV in drugs may not
be in the overall interest of the consumers.
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3. Sh. Praful Seth agreed with the views of
Chairman about the possibility of considering
the proposal for a limited number of non critical
drugs that is oral tonics etc. having obvious
animal tissues. He also explained that alternate
formulations are also available and the
physician may advice/educate consumers about
it.
4. Prof. S.D. Seth, and Sh. R.Anand Raj
Sekhar, opined that if at all proposals to mark
NV has to be considered it may be discussed
only for non-essential drugs.
5. Dr. Prem Agarwal, representative of IMA
opposed any move to bring in the concept of
V/NV in the field of medicines and also stated
that it would not be rational to further classify
drugs essential or non-essential for the purpose
of marking NV on the labels.
6. The Drugs Controller, Karnataka, was in
agreement to the extent of marking NV on nonessential drugs taken orally and containing
obvious animal tissues but did not favour the
concept of making V or NV in the field of drugs.
7. The president MCI, Dr Ketan Desai was of
opinion that marking products as NV is not
relevant for medicines and no attempt should
be made to differentiate them as essential and
non-essential once. The proposal may be
considered for food products and not for drugs.
8. Dr. Bhargava, representatives of Medical
Council of Indian, Dr. Gupta, Director, CDR
Lucknow and Mr. M.V. Kumar, expressed strong
views against, introducing the requirement for
marking drugs products with NV.
9. The mailer was discussed in great details
and the other members did not favour any
labelling of NV or V on the medicines.
In view of the above labelling of drugs
“V/NV” or “from animal source” as proposed in
the Agenda, was not accepted.”
(Emphasis
supplied).
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18. A citizen has the right to expression and receive
information under Article 19(1)(a) of the Constitution. That
right is derived from freedom of speech and expression
comprised in the Article. The freedom of speech and
expression includes the right to receive information. [Refer :
The State of U.P. vs. Raj Narain and othersl, (1975) 4
SCC 428; Secretary, Ministry of Information &
Broadcasting, Govt. of India and others vs. Cricket
Association of Bengal and others, (1995) 2 SCC 161;
P.V. Narasimha Rao vs. State (CBI/SPE), (1998) 4 SCC
626)]. But such right can be limited by reasonable restrictions
under the law made for the purpose mentioned in the Article
19(2) of the Constitution.
19. It is imperative for the State to ensure the availability of
the right to the citizens to receive information. But such
information can be given to the extent it is available and
possible, without affecting the fundamental right of others.
20. In the present case the appellant-Union of India had taken
a plea that information relating to the ingredients of drug
particularly those ingredients of non-vegetarian origin should
not be given “in the interest of general public”. A specific plea
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has been taken that it is not possible to distinguish the drugs
whether these are life saving or otherwise.
21. In the given circumstances the condition of a patient may
be such that a drug which is ordinarily not treated as a life
saving drug may be essential to save the life. In such a case
when drug becomes a life saving drug, it may not be desirable
for the patient or his attendant to know the origin of the
ingredients of the drug i.e. whether ‘vegetarian’ or ‘nonvegetarian’. Such option cannot be left on the patient or his
attendant if required to save the life or eradicate a disease.
22. The information about the origin of the ingredients of a
drug or cosmetic, if claimed as a matter of right, a vegetarian
can also claim information about the origin of a vegetarian
ingredient, depending upon his food habit.
23. Food habit in India varies from person to person and
place to place. Religion also plays a vital role in making such
habit. Those who follow ‘Jainism’ are vegetarian but many of
them do not eat some of the vegetarian food such as potato,
carrot, onion, garlic etc. which are grown below the earth.
Majority of Indians treat ‘honey’ and ‘lactose’ (milk derived
sugar) as vegetarian but scientists treat them as ‘nonvegetarian’ products.
23Page 24
Amongst the non-vegetarians a number of persons are
‘eggetarian’ i.e. those who only take one non-vegetarian
product–egg. They do not eat other non-vegetarian food like
animal, fish or birds. There are number of persons who treat
egg as vegetarian food. Even amongst non-vegetarians, a
large number of persons do not take beef or ham/pork because
of religious belief. Many of the non-vegetarians do not eat
snakes, insects, frog or bird.
In individual case, the Central Government may feel
difficulty in specifying the origin of a ‘vegetarian’ or ‘nonvegetarian’ ingredient, if a person wants to know the definite
origin of such ‘vegetarian’ or ‘non-vegetarian’ ingredient on the
basis of his food habit.
24. ‘The Drugs and Cosmetics Rules’ can be amended by the
Central Government after taking into consideration any
suggestion which the Drugs Technical Advisory Board may
make in relation to the amendments of the said Rules. Earlier
on a reference the Drugs Technical Advisory Board has already
opined that the labelling of drugs as ‘vegetarian’ or ‘non vegetarian’ or ‘from animal sources’ is not desirable and such
proposal was not accepted.
24Page 25
25. The question arises as to
whether in facts and
circumstances noted above, the High Court was justified in
issuing a writ of mandamus calling upon the Central
Government to discharge its duty by amending rules.
In A.K. Roy v. Union of India and others, (1982)
1 SCC 271, this Court considered the question
whether the Court should issue a mandamus calling
upon the Central Government to discharge its duty
without any further delay and held:
“The Parliament having left to the
unfettered judgment of the Central
Government the question as regards the time
for bringing the provisions of the 44th
Amendment into force, it is not for the
court to compel the government to do that
which, according to the mandate of the
Parliament, lies in its discretion to do
when it considers it opportune to do it.
The executive is responsible to the
Parliament and if the Parliament considers
that the executive has betrayed its trust
by not bringing any provision of the
Amendment into force, it can censure the
executive,…..”
26. The aforesaid decision was noticed and
reiterated by this Court in Supreme Court
Employees’ Welfare Association v. Union of India
and another, (1989) 4 SCC 187, and held:
“51. There can be no doubt that no court
can direct a legislature to enact a
particular law. Similarly, when an
executive authority exercises a legislative
25Page 26
power by way of subordinate legislation
pursuant to the delegated authority of a
legislature, such executive authority
cannot be asked to enact a law which he has
been empowered to do under the delegated
legislative authority.”
27. In Bal Ram Bali and another vs. Union of
India, (2007) 6 SCC 805, this Court discussed the
separation of powers while dealing with the
question of total ban on slaughter of cows,
horses, buffaloes and chameleon. This Court held
that it is a matter of policy on which decision
can be taken by the appropriate Government and the
Court cannot issue any direction to Parliament or
to the State Legislature to enact a particular
kind of law. The writ petition was held to be not
maintainable with the following observation:
“3. It is not within the domain of the
Court to issue a direction for ban on
slaughter of cows, buffaloes and horses as
it is a matter of policy on which decision
has to be taken by the Government. That
apart, a complete ban on slaughter of cows,
buffaloes and horses, as sought in the
present petition, can only be imposed by
legislation enacted by the appropriate
legislature. Courts cannot issue any
direction to the Parliament or to the State
legislature to enact a particular kind of
law. This question has been considered in
Union of India v. Prakash P. Hinduja and
Anr., (2003) 6 SCC 195, wherein in para 30
of the reports it was held as under:
26Page 27
“30. Under our constitutional scheme
Parliament exercises sovereign power
to enact laws and no outside power or
authority can issue a direction to
enact a particular piece of
legislation. In Supreme Court
Employees' Welfare Assn. v. Union of
India, (1989) 4 SCC 187, it has been
held that no court can direct a
legislature to enact a particular law.
Similarly, when an executive authority
exercises a legislative power by way
of a subordinate legislation pursuant
to the delegated authority of a
legislature, such executive authority
cannot be asked to enact a law which
it has been empowered to do under the
delegated legislative authority. This
view has been reiterated in State of J
and K v. A.R. Zakki, (1992) Supp.1 SCC
548. In A.K. Roy v. Union of India
(1982) 1 SCC 271, it has been held
that no mandamus can be issued to
enforce an Act which has been passed
by the legislature....”
4. In view of the aforesaid legal position,
we are of the opinion that this Court
cannot grant any relief to the petitioners,
as prayed for, in the writ petition. The
writ petition is accordingly dismissed.”
28. Learned counsel for the respondent writ
petitioner relied on the decision of this Court in
Union of India vs. Association for Democratic
Reforms and another, (2002) 5 SCC 294, and
submitted that the “field has remained unoccupied
this Court can issue such direction under Article
32 of the Constitution of India”, but such
submission cannot be accepted as it cannot be said
27Page 28
that field has remained unoccupied as under the
Drugs and Cosmetic Rules it is the Central
Government which in consultation with the Drug
Technical Advisory Board is empowered to decide
whether any amendment is to be made in the
relevant Rules showing the ingredients of
vegetarian or nonvegetarian origin or to provide
a symbol. In fact the issue in question was
deliberated by the Central Government when such
matter was referred to the Drug Technical Advisory
Board which in its 48th Meeting on 8th July, 1999
rejected such suggestion.
29. In view of the discussions above, we hold that
the High Court under Article 226 of the
Constitution of India has no jurisdiction to
direct the Executive to exercise power by way of
subordinate Legislation pursuant to power
delegated by the Legislature to enact a law in a
particular manner, as has been done in the present
case. For the same reason, it was also not open to
the High Court to suggest any interim arrangement
as has been given by the impugned judgment. The
writ petition filed by Respondent being not
28Page 29
maintainable for issuance of such direction, the
High Court ought to have dismissed the writ
petition in limine.
30. In the result, both the appeals are allowed
and the order and directions issued by the High
Court are set aside but there shall be no orders
as to costs.
…………………………………………………………………….J.
( G.S. SINGHVI )
…………………………………………………………………….J.
( SUDHANSU JYOTI MUKHOPADHAYA)
NEW DELHI,
MARCH 07, 2013.
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