Supreme Court of India
INDIAN SOAPS & TOILETRIES MAKERS ASSOCIATIONversusOZAIR HUSAIN AND OTHERS
- Citation
- 2013 INSC 141
- Decided
- 7 March 2013
- Disposal
- Appeal(s) allowed
- Bench
- G S SINGHVI
Holding
The High Court lacks jurisdiction to direct amendment of the Drugs and Cosmetics Rules for vegetarian/non‑vegetarian labeling, and such labeling is neither practicable nor desirable, so the High Court’s order is set aside.
Summary
The Delhi High Court, in a public‑interest writ, ordered manufacturers of drugs and cosmetics (other than life‑saving drugs) to display symbols indicating whether the product contained vegetarian or non‑vegetarian ingredients. The petitioners challenged this order, arguing that the Drugs and Cosmetics Act and Rules do not require such labeling and that the Central Government, after consulting the Drugs Technical Advisory Board, is the only authority to amend the rules. The Supreme Court examined the statutory scheme, the advisory board’s earlier rejection of the labeling proposal, and the constitutional limits on judicial direction under Article 226. It held that the High Court exceeded its jurisdiction by directing subordinate legislation and that mandating vegetarian/non‑vegetarian symbols is neither practicable nor desirable. Consequently, the High Court’s directions were set aside and the appeals were allowed.
Issues considered
- Whether the High Court has jurisdiction under Article 226 to direct the Central Government to amend the Drugs and Cosmetics Rules to require vegetarian/non‑vegetarian labeling of drugs and cosmetics.
- Whether it is practicable and desirable to display symbols indicating the vegetarian or non‑vegetarian origin of ingredients in drugs and cosmetics.
- Whether a writ of mandamus can be issued to compel the Central Government to amend the rules in the absence of a clear legislative mandate.
Legislation cited
- Constitution of Indias. Article 19(1)(a), s. Article 19(2), s. Article 21, s. Article 226, s. Article 25, s. Article 32
- Drugs and Cosmetics Act, 1940s. Section 16, s. Section 18A, s. Section 26A, s. Section 33, s. Section 3(aaa), s. Section 3(b), s. Section 5, s. Section 6, s. Section 7, s. Section 8
- Drugs and Cosmetics Rules, 1945s. Part XV (labelling), s. Rule 105, s. Rule 105A, s. Rule 149A, s. Rule 97
- Prevention of Food Adulteration Act, 1954
Subjects
vegetarian labelingdrugs and cosmeticsconsumer right to informationfreedom of speech and expressionArticle 226 jurisdictionmandatory labelingpublic interest litigationcentral government poweradvisory boardlife‑saving drugs
Judgment
(2013] 4 S.C.R. 675
INDIAN SOAPS & TOILETRIES MAKERS ASSOCIATION A
v.
OZAIR HUSAIN AND OTHERS
(Civil Appeal No. 5644 of 2003)
MARCH 7, 2013
B
[G.S. SINGHVI AND SUDHANSU JYOTI
MUKHOPADHAYA, JJ.]
Drugs and Cosmetics Rules, 1945 - Drugs and
Cosmetics Act, 1940 - Drugs - Ingredients of - Disclosure - C
Vegetarian I non-vegetarian - High Court in exercise of
jurisdiction u/Art. 226 of the Constitution directing the drug
manufacturers to display a particular symbol in the packages
of drugs other than life saving drugs to identify the ingredients
of 'non-vegetarian'! 'vegetarian' origin - Justification - Held: In D
a· given circumstance, the condition of a patient may be such
that a drug 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 E
i.e. whether 'vegetarian' or 'non-vegetarian' -Also, in individual
cases, the Central Government may feel difficulty in specifying
the origin of a 'vegetarian' or 'non-vegetarian' ingredient, if a
person wants to know the definite origin of such 'vegetarian'
or 'non-vegetarian' ingredient on the basis of his food habit - F
Under the Drugs and Cosmetic Rules, the Central
Government 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 non-vegetarian origin or to provide a symbol - G
Without fruitful consultation with the Advisory Board, no
amendment can be made or suggested to change the label
of the drugs and cosmetics - On an earlier reference, the
Advisory Board had aiready opined that the labelling of drugs
675 H
676 SUPREME COURT REPORTS [2013) 4 S.C.R.
A as 'vegetarian' or 'non-vegetarian' or 'from animal sources' is
not desirable - High Court u!Art. 226 had no jurisdiction to
direct the Executive to exercise power by way of subordinate
Legislation pursuant to power delegated by the Legislature to
enact a Jaw in a particular manner, as was done in the present
B case - For the same reason, it was also not open to the High
Court to suggest any interim arrangement as was given by
the impugned judgment - Constitution of India, 1950 - Art. 226.
Constitution of India, 1950 - Art.19(1)(a) and 19(2) -
Freedom of speech and expression - Right to receive
C information - Held: The freedom of speech and expression
includes the right to receive information - But such right can
be limited by reasonable restrictions under the law made for
the purpose mentioned in Art. 19(2) - It is imperative for the
State to ensure the availability of the right to the citizens to
D receive information - But such information can be given to the
extent it is available and possible, without affecting the
fundamental right of others.
The respondent filed writ petition (Public Interest
E Litigation) 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 by the impugned judgment held that
F the consumer has the fundamental right to know whether
the drugs other than life saving drugs are of non-
vegetarian or vegetarian origin and gave a finding to
provide certain mark on the labelling of such drugs
based on vegetarian or non-vegetarian origin.
G
The questions involved in the instant appeals were:
(i) Whether under Article 226 of the Constitution of
India, the High Court had jurisdiction to direct the
H manufacturers of drugs and cosmetics to display a
INDIAN SOAPS &TOILETRIES MAKERS ASSOCIATION v. 677
OZAIR HUSAIN
particular symbol in their packages to identify the A
ingredients of• non- vegetarian' or• vegetarian' origin; (ii)
Whether it was practicable and desirable to display any
identification as to the origin of the non-vegetarian
ingredients in the packages of drugs and cosmetics and
iii) Whether the High Court was justified in issuing a writ B
of mandamus calling upon the Central Government to
discharge its duty by amending the rules.
Allowing the appeals, the. Court
HELD: 1.1. The Drugs and Cosmetics Act, 1940 or C
the rules framed thereunder do not mandate mentioning
or 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 D
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
Advisor}' Board. Without fruitful consultation with the
Drugs Technical Advisory Board, no amendment can be E
made or suggested to change the label of the drugs and
cosmetics. [Para 16] [695-E-G]
1.2. Earlier a proposal was made by certain persons
to amend 'the Drugs and Cosmetics Rules, 1945' so as
F
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.
[Para 17] [695-H; 696-A-B]
G
2. 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. But H
678 SUPREME COURT REPORTS [2013] 4 S.C.R.
A such right can be limited by reasonable restrictions under
the law made for the purpose mentioned in the Article
19(2) of the Constitution. 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
B extent it is available and possible, without affecting the
fundamental right of others. [Paras 18, 19) [698-G; 699-
A-B]
The State of U.P. vs. Raj Narain and Others (1975) 4
SCC 428: 1975 (3) SCR 333; Secretary, Ministry of
C Information & Broadcasting, Govt. of India and Others vs.
Cricket Association of Bengal and Others (1995) 2 SCC 16t:
1995 (1) SCR 1036 and P. V. Narasimha Rao vs. State (CBI/
SPE) (1998) 4 SCC 626: 1998 (2) SCR 870 - referred to.
D 3.1. 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
E know the origin of the ingredients of the drug i.e. whether
'vegetarian' or 'non-vegetarian'. Such option cannot be
left on the patient or his attendant if required to save the
life or eradicate a disease. [Para 21) [699-0-E]
3.2. The information about the origin of the
F 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. Food habit in India varies from person to
person and place to place. Religion also plays a vital role
G in making such habit. In individual case, the Central
Government may feel difficulty in specifying the origin of
a 'vegetarian' or 'non-vegetarian' ingredient, if a person
wants to know the definite origin of such 'vegetarian' or
'non-vegetarian' ingredient on the basis of his food habit.
H [Paras 22, 23) [699-F-G; 700-C-D]
INDIAN SOAPS & TOILETRIES MAKERS ASSOCIATION v. 679
OZAIR HUSAIN
4.1. 'The Drugs and Cosmetics Rules' can be A
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 B
labelling of drugs as 'vegetarian' or 'non-vegetarian' or
'from animal sources' is not desirable and such proposal
was not accepted. [Para 24] [700-D-E]
4.2. The plea of the respondent that the field has
remained unoccupied and thus this Court can issue C
direction under Article 32 of the Constitution cannot be
accepted as u·nder the Drugs and Cosmetics 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 D
Rules showing the ingredients of vegetarian or non-
vegetarian origin or to provide a symbol. [Para 28] [702-
G-H; 703-A-B]
A.K. Roy v. Union of india and Others (1982) 1 SCC 271: E
1982 (2) SCR 272; Supreme Court Employees' Welfare
Association v. Union of India and Another (1989) 4 SCC 187:
1989 (3) SCR 488; Bal Ram Bali and Another vs. Union of
India (2007) 6 SCC 805 and Union of India vs. Association
for Democratic Reforms and Another (2002) 5 SCC 294: 2002 F
(3) SCR 696 - referred to.
5. 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 G
Legislature to eni:ict 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
H
680 SUPREME COURT REPORTS [2013] 4 S.C.R.
A judgment. The writ petition filed by Respondent being not
maintainable for issuance of such direction, the High
Court ought to have dismissed the writ petition in limine.
The order and directions issued by the High Court are set
aside. [Paras 29, 30). [703-C-F]
B
Case Law Reference:
1975 (3) SCR 333 referred to Para 18
1995 (1) SCR 1036 referred to Para 18
c 1998 (2) SCR 870 referred to Para 18
1982 (2) SCR 272 referred to Para 25
1989 (3) SCR 488 referred to Para 26
D c2001) 6 sec 805 referred to Para 27
2002 (3) SCR 696 referred to Para 28
CIVIL APPELLATE JURISDICTION : Civil Appeal No.
5644 of 2003.
E
From the Judgment & Order dated 13.11.2002 of the High
Court of Delhi at New Delhi in Civil Writ Petition No. 837 of
2001.
WITH
F Civil Appeal No. 5645 of 2003.
T.S. Doabia, Raj Panjwani, Amar Dave, Radhika Gautam,
Gaurav Goel (for E.C. Agrawala), R.K. Rathore, Sunita Sharma,
Shalinder Saini, D.S. Mahra, Aditya Shamlal, Vijay Panjwani,
G B.V. Balaram Das for the appearing parties.
The Judgment of the Court was delivered by
SUDHANSU JYOTI MUKHOPADHAYA, J. 1. These
appeals have been preferred by the appellants against the
H judgment dated 13th November, 2002 passed by the Division
•
INDIAN SOAPS & TOILETRIES MAKERS ASSOCIATION v. 681
OZAIR HUSAIN [SUDHANSU JYOTI MUKHOPADHAYA, J.]
Bench of the Delhi High Court in a Public Interest Litigation (Civil A
Writ Petition No.837 of 2001) whereby the High Court held that
the consumer has the fundamental right to know whether the
food products, cosmetics and drugs available for human
consumption are of non-vegetarian or vegetarian origin and
ordered as follows: B
"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 C
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 o
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:-
E
(2) Where a cosmetic or a drug other than life
saving drug, as the case may be, contains ingredients F
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:-
G
H
682 SUPREME COURT REPORTS [2013] 4 S.C.R.
A (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
B
Controller General, 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
C 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
o 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
E 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
F practise vegetarianism. In the aforesaid context, freedom
of expression enshrined in Arlicle 19(1)(a) can seNe 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
G 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 Arlicle 21 grants freedom to an individual
to follow and to stick to his opinions, and for pursuing
H
INDIAN SOAPS & TOILETRIES MAKERS ASSOCIATION v. 683
OZAIR HUSAIN [SUDHANSU JYOTI MUKHOPADHAYA, J.]
such a course he had right to receive information and A
also a right to know the ingredients or the constituents of
cosmetics, drugs and food products."
"...... In view of the aforesaid discussion, we are of
the view that it is the funrJamental right of the consumers B
to know whether the food products, cosmetics and drugs
are of non- vegetarian 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 C
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 ...... " D
" ...... 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 non- vegetarian. As regards drugs and E
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 F
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 G
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. Jn many cases
patients are unconscious and they have to be put on life
H
684 SUPREME COURT REPORTS (2013) 4 S.C.R.
A 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
B 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.
c "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
D 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 Savrng Drug', can be used as a Life Saving
E 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
F 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
G 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.
5. Further, according to the learned counsel for the Union
H of India, the direction of the High Court for affixing Red Label
INDIAN SOAPS & TOILETRIES MAKERS ASSOCIATION v. 685
OZAIR HUSAIN [SUDHANSU JYOTI MUKHOPADHAYA, J.]
which is symbolic of danger on drugs and cosmetics is A
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 B
wherein t.he reason was shown for not providing any
identification as to 'ingredient of non-vegetarian origin'.
6. Learned counsel appearing on behalf of the appellant-
Indian Soaps & Toiletries Makers Association (hereinafter
referred to as the 'Association') submitted that it is neither C
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 D
that it is difficult to identify the origin of non-vegetarian
ingredients, as it is very difficult to know the basic source from
which such ingredient is derived.
7. The following arguments were also advanced on behalf E
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 eafing. Thr.refore, the sentimental F
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 G
vegetarian and non-vegetarian 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 H
686 SUPREME COURT REPORTS [2013] 4 S.C.R.
A amongst consumers about cosmetic composition.
(b) Unlike the food industry where the processing of
food takes place neqr to the primary produce or a
step away from the primary produce center and not
many intermediary stages are involved before the
B
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
c 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
D 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
E 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
F will defeat the very purpose for which such
requirement is intended.
(d) Unlike food products which are normally
manufactured and consumed in India, barring a
few exceptions, the cosmetic industry competes
G 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
H also place the Petitioners members at
INDIAN SOAPS & TOILETRIES MAKERS ASSOCIATION v. 687
OZAIR HUSAIN [SUDHANSU JYOTI MUKHOPADHAYA, J.]
disadvantage in competing with international A
cosmetic products. Such labelling without any
technology for analysis is a/so 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 B
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 C
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 D
standard reference books- The Chemistry &
Manufacture of Cosmetics by Maison deNavaree,
Allured Publishing.
(2) Schedule S of Drugs & Cosmetics Act recognizes E
29 of such types of cosmetics.
(3) Each type of formulation has wide choice of 12,000
ingredients approved by CTFA or INC/ directory
of ingredients and are safe for use in cosmetic
products. Ref.: CTFA on-line web site. F
(4) In fact, some of the INC/ ingredients are mixture
of ingredients in various proportions of similar
compounds. For example, commonly used
CARBOMER is a homopo/ymer of acrylic acid G
cross linked with ally/ ether of pentaerythritol, ally/
ether of sucrose or ally/ ether of propylene. It has
7 different technical names based on different
grades, 32 trade names and 7 trade name
mixtures.
H
688 SUPREME COURT REPORTS [2013] 4 S.C.R.
A (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
B 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.
c (6) All of these ingredients are purified several times
to reach the acceptable form as required by INC/
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.
D 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
E 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
F 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
G difficult to check and certify the origin of
ingredients used.
9. It was also contended that the power of determination
of labelling requirements including their contents is vested with
H the Union of India's authorities such as the Drug Technical
INDIAN SOAPS & TOILETRIES MAKERS ASSOCIATION v. 689
OZAIR HUSAIN [SUDHANSU JYOTI MUKHOPADHAYA, J.]
Advisory Board. In such case the High court ought not to have A
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 B
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 C
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.
D
11. The questions involved in this case are:
(i) Wnether under Article 226 of the Constitution of
India the High Court has jurisdiction to direct the
manufacturers of drugs and cosmetics to display E
a particular symbol in their packages to identify
the 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- F
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 G
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 H
690 SUPREME COURT REPORTS [2013] 4 S.C.R.
A 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
B 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
c by a symbol and colour code so stipulated for the said purpose,
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)
D 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.
E
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
F as follows:
"3(b) "drug" includes-
(iJ all medicines for internal or external use of human
beings or animals and all substances intended to
G 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;
H
INDIAN SOAPS & TOILETRIES MAKERS ASSOCIATION v. 691
OZAIR HUSAIN [SUDHANSU JYOTI MUKHOPADHAYA, J.]
(ii) such substances (other than food) intended to A
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 may be specified
from time to time by the Central Government by B
notification in the Official Gazette;
(iii) all substances intended for use as components of
a drug including empty gelatine capsules; and
(iv) such devices intended for internal or external use C
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; D
'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 E
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. "
F
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 oufother functions assigned to ii by the Act. The G
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
H
SUPREME COURT REPORTS [2013] 4 S.C.R.
692
A Council of India; etc.
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
8 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
C and cosmetics have been prescribed. Chapter Ill 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
D 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
E 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
F 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
G
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:
H Provided that consultation with the Board may be
INDIAN SOAPS &TOILETRIES MAKERS ASSOCIATION v. 693
OZAIR HUSAIN [SUDHANSU JYOTI MUKHOPADHAYA, J.)
dispensed with if the Central Government is of opinion A
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 B
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 c
xxx xxx xxx
(i) prescribe the conditions to be observed in the packing
in bottles, packages, and other containers of drugs or
0
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;
E
(}) 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 F
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.
Rule 149A is a special provision relating to toothpaste G
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': H
694 SUPREME COURT REPORTS [2013) 4 S.C.R.
A "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' -
B
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
c on the left top comer of the label and be also labelled
with the following words:-
Sch(ldule H drug-Warning: To be sold by retail on the
prescription of a Registered Medical Practitioner only';
D
(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,
E 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
F
labelled with the symbol XRx which shall be in red
conspicuously displayed on the left top comer of the label
and be also labelled with the words : -
Schedule X drug -"Warning:-- To be sold by retail on the
G 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
H with the word in capital 'For External use only'.
INDIAN SOAPS & TOILETRIES MAKERS ASSOCIATION v. 695
OZAIR HUSAIN [SUDHANSU JYOTI MUKHOPADHAYA, J.]
(3)The container of a medicine made up ready only for A
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.
B
(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". c
(5) Substances specified in Schedule X in bulk form shall
bear a label wherein they symbol as specified in sub-rule
(1) shall be given conspicuously in red letters."
Whereas Rule 105 relates to packing of drugs, including D
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 E
framed thereunder do not mandate mentioning or 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. F
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 G
or suggested to change the label of the drugs and cosmetics.
17. Earlier a proposal was made by certain persons to
H
696 SUPREME COURT REPORTS [2013] 4 S.C.R.
A 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:
B
"AGENDA ITEM N0.3
PROPOSAL TO AMEND DRUG & COSMETIC RULE
1945 TO REQUIRE MENTION OF WORDS
V(VEGITAIAN) AND NV(NON VEG/TAR/AN) ON
LABELS OF DRUGS/COSMETICS
c
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
D Board Members with their views on this subject. Sh.
Chhotray, explained regarding his Ministry's 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
E 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
F 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.
G
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
H
INDIAN SOAPS &TOILETRIES MAKERS ASSOCIATION v. 697
OZAIR HUSAIN [SUDHANSU JYOTI MUKHOPADHAYA, J.]
products like vaccines, harmones, Biotech products etc. A
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 B
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 C
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
/CMR felt that what may be appropriate in case of food D
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 E
interest of the consumers.
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. F
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.O. Seth, and Sh. R.Anand Raj Sekhar, opined
that if at all proposals to mark NV has to be considered G
it may be discussed only for non-essential drugs.
5. Dr. Prem Agarwal, representative of /MA opposed any
move to bring in the concept of VINV in the field of
H
698 SUPREME COURT REPORTS [2013) 4 S.C.R.
A 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, Kamataka, was in agreement to
the extent of marking NV on non-essential drugs taken
B 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
c 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
D 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
E 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. "
F (Emphasis supplied)
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
G 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 Others, (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;
H
INDIAN SOAPS & TOILETRIES MAKERS ASSOCIATION v. 699
OZAIR HUSAIN [SUDHANSU JYOTI MUKHOPADHAYA, J.]
P.V. Narasimha Rao VS. State (CBl/SPE), (1998) 4 sec 626)]. A
But such right can !:>e 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 B
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 C
particularly those ingredients of non-vegetarian origin sho 11ld not
be given "in the interest of general public". A specific plea has
been taken that it is not possible to distinguish the drugs
whether these are life saving or otherwise.
D
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 E
ingredients of the drug i.e. whether 'vegetarian' or 'non-
vegetarian'. 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 F
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 G
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 'non-vegetarian' H
700 SUPREME COURT REPORTS [2013) 4 S.C.R.
A products.
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
B 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.
C In individual case, the Central Government may feel
difficulty in specifying the origin of a 'vegetarian' or 'non-
vegetarian' ingredient, if a person wants to know the definite
origin of such 'vegetarian' or 'non-vegetarian' ingredient on the
basis of his food habit.
D
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
E 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.
25. The question arises as to whether in facts and
F 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 AK. Roy v. Union of India and Others, (1982) 1 SCC
G 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
H
INDIAN SOAPS &TOILETRIES MAKERS ASSOCIATION v. 701
OZAIR HUSAIN [SUDHANSU JYOTI MUKHOPADHAYA, J.]
regards the time for bringing the provisions of the 44th A
Amendment into forcP., 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 B
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 C
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 power by way D
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."
E
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
F
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 G
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 H
702 SUPREME COURT REPORTS [2013] 4 S.C.R.
A 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
B ii was held as under:
"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
c Court Employees' Welfare Assn. v. Union of India,
(1989) 4 sec 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
D 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
E v. AR. Zakki, (1992) Supp.1 SCC 548. In A.K.
Roy v. Union of India (1982) 1 SCC 271, it has
be~n held that no mandamus can be issued to
enforce an Act which has been passed by the
legislature .... "
F
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
pet1t1on is accordingly dismissed."
G 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
sec 294, and submitted that the "field has remained
·~noccupied this Court can issue such direction under Article
H 32 of the Constitution of India", but such submission cannot be
INDIAN SOAPS & TOILETRIES MAKERS ASSOCIATION v. 703
OZAIR HUSAIN [SUDHANSU JYOTI MUKHOPADHAYA, J]
accepted as ii cannot be said that field has remained A
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 non-vegetarian origin or to provide B
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
c
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 D
open to the High. Court to suggest any interim arrangement as
has been given by the impugned judgment. The writ petition filed
by Respo_1'dent being not maintainable for issuance of such
direction the High Court ought to have dismissed the writ
petition ih limine. E
3~. 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.
B.B.B. F
Appeals allowed.
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