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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  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  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  non-   vegetarian.   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  appellant-

Indian  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  non-

vegetarian 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  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  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 non- essential  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  ‘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  

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  ‘non-

vegetarian’ products.  

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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  ‘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.

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.  

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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  

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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:

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“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 respondent­writ  

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  

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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  

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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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