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PETITIONER: ISHWAR SINGH BINDRA & ORS.

       Vs.

RESPONDENT: THE STATE OF U.P.

DATE OF JUDGMENT: 02/05/1968

BENCH: GROVER, A.N. BENCH: GROVER, A.N. HIDAYATULLAH, M. (CJ) VAIDYIALINGAM, C.A.

CITATION:  1968 AIR 1450            1969 SCR  (1) 219  CITATOR INFO :  RF         1986 SC1162  (5)

ACT: Drugs  Act,  1940 s. 3(b)(i)-Definition of  ’drug-Scope  of- Medicines  and  substances  used  or  prepared  for  use  in accordance with Ayurvedic or Unani systems-When excluded.

HEADNOTE: The  Inspector of Drugs, Agra Region, filed a  complaint  in July  1963  be,  fore a Magistrate  at  Mathura  alleging  a preparation called anti-phlogistic plaster was  manufactured and  sold by a firm of which the first two -appellants  were partners and the third appellant was the Manager; the  label on  the  plaster showed the constituents to be  three  drugs which are to be found in pharmacopoeias prescribed under the Drugs  Act,  1940 but did not bear a  manufacturing  licence number  and other particulars required to be given under  r. 96  of  the Drug Rules, 1945.  As the drug fell  within  the mischief  of  s. 17(e) of the Act, it must be deemed  to  be ’misbranded’.  Moreover the label of the plaster showed that it was -a Unani preparation which was apparently a false and misleading   claim.   Accordingly,-  it  was  alleged   that offences had been committed under s. 18(a)(ii) read with ss. 27(a)  and (b) of the Act for selling a misbranded  drug  as per s. 17(f) and s. 17(e) respectively of the Act and  under s. 18(b) lead with s. 27(b) of the Act for selling the  same drug which had been manufactured without a licence  required for the purpose under the Act. The  appellants  filed  a  petition under  s.  561A  of  the Criminal Procedure Code in the High Court in March 1964  and claimed  inter  alia  that the plaster was  not  a  drug  as defined  in the Act and praying that the entire  proceedings pursuant to the complaint be quashed.  It was contended that in  the definition. of a drug in s. 3 (b) (i) of the Act  in the   expression  "other  than  medicines   and   substances exclusively used or prepared for use in accordance with  the Ayurvedic   or  Unarni  Systems  of  medicine’  the   adverb "exclusively"  governed  the  word "use’ only  and  did  not govern the words "prepared for use".  The High Court was  of the  view that the intention of the legislature appeared  to be to exclude from the definition of drug such medicines and

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substances  which were used exclusively in  accordance  with the  Ayurvedic  or Unani system of medicine  or  which  were prepared   for  use  exclusively  in  accordance  with   the aforesaid  system; but it declined to go into  the  disputed questions  of  fact as to whether the plasters  in  question fell  within  the  exception  as this  was  required  to  be determined on expert evidence On   appeal to this Court by certificate, HELD: dismissing the appeal : The  expression  "substances"  in  the  definition  of  drug contained in s.     3(b)   means   something   other    than "medicines".  The word "and" used in the definition of  drug in s. 3(b)(i) between "medicines" and "substances" is to  be read disjunctively. [225 F--G] The scheme of cl. (i) of s. 3(b) is to take in all medicines substances   with  the  exception  of  such   medicines   or substances which are 220 exclusively used or prepared for use in accordance with  the Ayurvedic or Unani system of medicines.  The exception  made in  the case of the latter class of medicines or  substances was  essentially  meant  to cover  only  such  medicines  or substances which were used in the Ayurvedic or Unani  system or  were prepared for use in accordance with those  systems. [226 A-B] Medicines  or substances have to be taken as a whole and  in the  present cases it would have to be decided by the  trial court  whether the plasters in question are medicines  which are  exclusively  used or which have been prepared  for  use exclusively in accordance with the Ayurvedic or Unani system of medicine.  The High Court was right in its view that  the adverb  "exclusively"  must  be taken to  govern  the  words "used"  as well as "prepared for use"; but  each  individual ingredient or component of the preparation in question  will not be the decisive or determining factor and what the court will have to decide after recording such evidence as may  be Produced  will  be whether the plasters  satisfy  the  above test.  If they fulfill that test they would be excluded from the definition of drug as contained in s. 3 (b) (i). [226 E- G] Chimanlal Jagjivandas Sheth v. State of Maharashtra,  [1963] Supp.   1 S.C.R. 344; Stroud’s Judicial Dictionary  3rd  Ed. 135  and  Maxwell on Interpretation of  Statutes,  11th  Ed. referred to.

JUDGMENT: CRIMINAL APPELLATE JURISDICTION : Criminal Appeals Nos.  190 and 191 of 1965. Appeals from the judgment and order, dated July 20, 1965  of the  Allababad High Court in Criminal Mis.  Cases  Nos.  562 and 563 of 1964. Bishan Narain and Harbans Singh, for the appellants. G. N. Dikshit and    O. P. Rana, for the respondents. The Judgment of the Court was delivered by Grover,  J.-These are two companion appeals by  certificates from  the  judgment  of  the High  Court  of  Judicature  at Allahabad  dismissing  two petitions under s.  561A  of  the Criminal  Procedure Code in which the sole  question  raised related  to the true and correct interpretation of s. 3  (b) (i)  of  the  Drugs  Act  1940.  as  it  stood  before   the enforcement  of the Drugs (Amendment) Act 1962 (Act  XXI  of 1962) and the Drugs and Cosmetics (Amendment) Act 1964  (Act XIII of 1964).

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As  the  point involved is common to both  the  appeals  the facts in Cr.  Appeal No. 190 of 1965 may be shortly  stated. The  first  two appellants are the partners  and  the  third appellant  is the manager of Bindra’s  Chemical  Corporation which carries on the manufacture of medicines and substances in  accordance  with  the Ayurvedic  and  Unani  systems  of medicines at Delhi, Shahdara.  The Inspector of Drugs,  Agra Region, filed a complaint dated July 2, 1963 in the court of Magistrate,  First Class, at.  Mathura alleging  inter  alia that  on  September 20, 1962 when he was  carrying  out  the inspection of the shop of M/s Frontier Gupta Medical Stores, Mathura, he came across a preparation 221 called Antiphlogistic Plaster.manufactured by the  aforesaid Corporation.  On examining the label it was discovered  that although the name of three drugs i.e. Glycerine, Kaolin  and Boric,  Acid  which  are  to  be  found  in   Pharmacopoeias prescribed under the Act were mentioned as constituent,,  of the  plaster, the label did not bear  manufacturing  Licence Number and other particulars with which a drug was  required to be labelled in accordance with Rule-96 of the Drug  Rules 1945.  According to the Inspector this drug fell within  the mischief of s. 17 (e) of the Act and was to be deemed to  be misbranded  as  it had not been labelled in  the  prescribed manner.   Moreover  the  label of the  plaster  in  question showed that it was a Unani preparation which was  apparently a  false  and misleading claim.  A sample was  sent  to  the Government Analyst who gave a certificate dated October  25, 1962  to the effect that it contained Glycerine, Kaolin  and Boric   Acid  and  that  Glycerine  and  Boric   Acid   were pharmacopoeal drugs which were not exclusively Ayurvedic  or Unani   medicines.    According  to   the   Inspector,   the Antiphlogistic Plaster was a misbranded drug as per s. 17(e) &  (f)  of the Act.  It was alleged that offences  had  been committed under s. 18 (a) (ii) read with ss. 27 (a) and  (b) of  the  Act  for selling  Antiphlogistic  Plaster,  a  drug "misbranded"  as per S. 17(f) and s. 17(e)  respectively  of the  Act and under S. 18 (b) read with S. 27 (b) of the  Act for  selling  the  same drug  which  had  been  manufactured without a licence required for the purpose under the Act, to M/s Frontier Gupta Medical Stores, Mathura. On  March 24, 1964 the appellants filed a petition under  S. 561A  of  the  Code in the High Court raising  a  number  of points  including  the question of the jurisdiction  of  the Court at Mathura to entertain the complaint as also that the Antiphlogistic Piaster was not a drug as defined in the  Act and  praying  that the entire proceedings  pursuant  to  the complaint  be  quashed.  In *he affidavit  accompanying  the petition  it  was stated that the ingredients  used  in  the preparation  of  Bindra’s  Antiphlogistic  Plaster  were  in accordance  with  the.   Unani system  of  medicine.   These ingredients were (i) Glycerine, (ii) Kaolin i.e. Gule Armani or  Chikaimati,  (iii) Bora i.e. Boric, (iv) Oil  of  Winter green i.e. Java, (v) Oil of Eucalyptus, and Safeda.  It  was asserted   that  all  the  six  components  were   medicines recognised under the Unani system and merely because one  of the  components was used in the Allopathic system  also  the medicine would not become a drug when the whole  preparation itself  was  an Ayurvedic medicine.  Reference was  made  to certain  books  like  Ramooz-UI-Taba,  Kitabul  Davaiya  and Kantz-UI-Taba  which  were  well known books  of  the  Unani system  of  medicine  in  which  Glycerine  and  Boric  were recognised  as  medicines used in that  system.   The  other components  of  the  plaster were, it is  stated,  of  Unani origin  and frequently used for preparations  in  accordance

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with Ayurve- 222 dic  and  Unani  system.  The Inspector  of  Drugs  filed  a counter   affidavit  in  which  it  was  pointed  out   that Glycerine, Kaolin and Boric Acid were drugs which were to be found  in  the  British  Pharmaceutical  Codex  1958.    The "monographs"  of Glycerine, heavy Kaolin, light  Kaolin  and Boric Acid containing the formulae according to which  these drugs  were prepared were given.  It was also  alleged  that Bindra’s   Antiphlogistic  Plaster  had  been  prepared   in accordance with the Allopathic system of medicine since  its composition  resulted  in  a  preparation  known  as  Kaolin Poultice  given  at page 359 of the  British  Pharmaceutical Codex 1958.  Glycerine, Boric Acid, Kaolin and oil of winter green Methyl Salicylate were the main components of Bindra’s Antiphlogistic  Plaster and those were medicines which  were not exclusively used in accordance with either the Ayurvedic or  the Unani system of medicine.  In the further  affidavit filed by the appellants it was maintained that Glycerine and Kaolin and Boric Acid were being used in the Unani system in the same way as many other things such as Honey,  Rosewater, Boric  or  Sohaga,  Sulphur  i.e.  Gandhak,  Arsenic   i.e., Sankhia,  Alum  i.e.  Phtkari which were  mentioned  in  the British Pharmaceutical Codes but it did not follow that they could  not  be used in a preparation made according  to  the Ayurvedic  system.   It was pointed out  that  the  medicine known  as  Kaolin  Poultice  was  entirely  different   from Bindra’s Antiphlogistic Plaster. The  definition  of "drug" contained in s. 3 (b) is  in  the following terms :-               (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  disease  in  human  beings  or               animals  other than medicines  and  substances               exclusively  used  or  prepared  for  use   in               accordance with Ayurvedic or Unani systems  of               medicine.               (ii)  such   substances  (other   than   food)               intended  to  affect  the  structure  or   any               function  of the human body or intended to  be               used for the destruction of vermin or  insects               which   cause  disease  in  human  beings   or               animals, as may specified from time to time by               the Central Government by notification in  the               Official Gazette." The  contention of the appellants before the High Court  was that  in the last part of cl. (1) the  adverb  "exclusively" governed  the word "used" only and did not govern the  words "prepared  or use".  The other argument raised was that  the legislature  intended to except from the definition of  drug medicines and sub- 223 stances  which were, common to Ayurvedic or Unani system  of medicine and other systems.  The High Court was of the  view that  the  intention of the legislature appeared  to  be  to exclude  from  the  definition of drug  such  medicines  and substances  which were used exclusively in  accordance  with the  Ayurvedic  or Unani system of medicine  or  which  were prepared   for  use  exclusively  in  accordance  with   the aforesaid  system.   In  other words it was  held  that  the adverb  "exclusively" governed "use" as well as  "  prepared for  use".  The High Court declined to go into the  disputed questions  of  fact as to  whether  Bindra’s  Antiphlogistic

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plaster  fell  within the exception and was not a  drug  and observed  that  the question as to whether a medicine  or  a substance   was  used  exclusively  or  prepared   for   use exclusively in accordance with the Ayurdevic or Unani system of  medicine was a question of fact, the decision  of  which would hinge inter alia on expert evidence. It has been urged by Mr. Bishan Narain that on a true inter- pretation  of the words embodying the exception  a  medicine which  has  been  prepared for use in  accordance  with  the Ayurvedic  or Unani system would fall within  the  exception notwithstanding   the   ,use  of  certain   medicines   like Glycerine, Boric Acid etc. which are used in the  Allopathic system as also in the Ayurvedic or Unani systems.  By way of illustration,  in  the Unani system fat was  being  used  in preparation  of certain medicines and instead of  fat  being used  now Glycerine is being used.  This, according  to  Mr. Bishan  Narain, will not take the entire preparation of  the Antiphlogistic  Plaster  as such outside the  scope  of  the exception in the definition of drug in the Act.  An  attempt has,  also  been  made  to show,  by  reference  to  certain provisions  of the Act, that the Government Analyst to  whom the  sample of the plaster was sent, was not  qualified  and indeed  could not be qualified to express any opinion  about medicines  used or prepared for use in accordance  with  the Ayurvedic and Unani systems. The position taken up on behalf of the State is that in fact and  substance all the drugs and medicines mentioned in  the British  Pharmaceutical  Codex  have been  employed  in  the preparation  of  Bindra’s  Antiphlogistic  Plaster.   It  is strenuously contended that by a simple device of calling  it a  Unani  or  Ayurvedic  preparation  in  which   admittedly Glycerine,  Kaolin,  Boric Acid etc. have been  used,  which find  place in British Pharmaceutical Codex and are  clearly drugs,  the  appellants cannot escape  the  consequences  of infringement of the provisions of the Act. At  this stage it would be useful to refer to some  of  the, important provisions of the Act.  It was enacted to regulate the  import, manufacture,, distribution and sale  of  drugs. The  definition  of drug as given. in s. 3.(b) was  made  as wide  as it could be and the only exception related  to  the medicines and substances 224 used  or  prepared for use exclusively in the  Ayurvedic  or Unani system. Chapter IV contains provisions relating to manufacture, sale and distribution of drugs.  Section 16 says, the  expression "  standard quality" when applied to a drug means  that  the drug  complies  with the standard set out in  the  Schedule. Section   17  relates  to  misbranded  drugs.   Section   18 prohibits   manufacture  and  sale  of  sub-standard   drugs including  misbranded drugs.  Sections 20 & 21  provide  for the  appointment of Government Analysts and Inspectors,  the procedure  to  be  followed  by  them  and  the  reports  of Government  Analysts.  Section 27 contains the  penalty  for manufacture, sale etc. of drugs in contravention of  Chapter IV; the punishments provided being quite severe. A number of amendments were made by Act XIII of 1964 some of which  may be noticed.  These are strictly not relevant  for our purposes except for understanding the legislation on the subject.   In  cl. (1) the words "other than  medicines  and substances   exclusively  used  or  prepared  for   use   in accordance  with the Ayurvedic or Unani system of  medicine" were  deleted.  Before clause (aa) the following clause  was inserted :               (a)  "Ayurvedic  (including Siddha)  or  Unani

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             drug"includes   all  medicines  intended   for               internal  or  external  use  for  or  in   the               diagnosis, treatment mitigation or  prevention               of disease in human beings, mentioned in,  and               processed  and  manufactured  exclusively   in               accordance with the formulae described in, the               authoritative  books of  Ayurvedic  (including               Siddha)  and Unani Tibb) system  of  medicine,               specified in the First "Schedule" Chapter  IV-A  was added containing provisions  relating  to Ayurvedic including Siddha and Unani drugs.  According to S. 33(e)  in that Chapter, from such date, as may be  fixed  by the State Government by notification in the official gazette no person shall himself or by any other person on his behalf sell  or  stock  or exhibit for  sale,  or  distribute,  any Ayurvedic  (including Siddha) or Unani drug other than  that manufactured by a manufacturer licensed under this  Chapter. Penalties   were  provided  for  the  infringement  of   the provisions contained in the Chapter. There can be no difficulty now after the amendments made  by Act  XIII of 1964 in the matter of medicines and  substances exclusively used or prepared for use in accordance with  the Ayurvedic  or  Unani system of medicine  provided  they  are processed  and  manufactured  according  to  the   formulae, described  in  the authoritative books as specified  in  the First  Schedule.   The  difficulty,  however,  remains  with regard to the true import of the 225 exception  in  the  definition of "drug"  in  the  Act.   In Chimmanlal Jagjivandas Sheth v. State of Maharashtra(1)  the appellant had been prosecuted for an, offence under s. 18 of the  Act  inter alia for manufacturing drugs which  were  of sub-standard  quality.  Certain samples of absorbent  cotton wool,  roller bandages and guaze which he  had  manufactured were seized and he had not only stored them but he was  also passing them off as though they were manufactured by a  firm of  repute  at  Secunderabad.  The  Government  Analyst  had reported that only the lint was of standard quality and  the other articles were not of standard I quality.  He had  been convicted and sentenced to undergo rigorous imprisonment for three  months and to pay a fine of Rs. 100 under each  count by  the  High  Court on  appeal  against  acquittal.   After setting out the definition of drug as given in s. 3(b)  this Court observed:               "The said definition of drug is  comprehensive               enough to take in not only medicines but  also               substances  intended to be used for or in  the               treatment  of  diseases  of  human  beings  or               animals.     This    artificial     definition               introduces  a. distinction  between  medicines               and   substances  which  are   not   medicines               strictly    so   called.     The    expression               ’substances’,  therefore,  must  be  something               other  than medicines but which are  used  for               treatment. The   dictionary  meaning  of  the  words   "medicines   and substances"  may  be  noticed.  In  Shorter  Oxford  English Dictionary   the  appropriate  meaning  of   "medicine"   is "medicament  especially  one  taken   internally--medicament generally".    The  meaning  substance"  relevant  for   our purposes  is  "any  particular kind,  of  corporeal  matters species of matter of a definite chemical positions piece  or a  mass of particular kind of matters a body of a  specified composition or texture." Now  if the, expression "substances" is to be taken to  mean

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something  other  than "medicine" as has been  held  in  our previous decision it becomes difficult to understand how the word "and" as used in the definition of drug in s. 3 (b) (i) between   "medicines"  and  "substances"  could  have   been intended to have been used conjunctively.  It would be  much more  appropriate in the context to read  it  disjunctively. In  Stroud’s  Judicial Dictionary, 3rd Ed. it is  stated  at page  135  that  "and" has Generally  a  cumulative,  sense, requiring,  the  fulfillment of all the conditions  that  it joins  together,  and herein it is the antithesis  of  "or". Sometimes,  however,  even in such a connection, it  is,  by force of a contents, read as "or".  Similarly in Maxwell  on Interpretation  of Statutes, 11th Ed., it has been  accepted that  "to carry out the intention of the legislature  it  is occasionally  found necessary to read the conjunctions  ’or’ and ’and’ one for the other". (1) [1963] Sup.  1 S.C.R. 344. LO SuP.  C. I/68-16 226 The  scheme of cl. (i) of S. 3(b) apparently is to  take  in all  medicines  or  substances with the  exception  of  such medicines  or  substances  which  are  exclusively  used  or prepared  for use in accordance with the Ayurvedic or  Unani system  of  medicine.   The exception made in  the  case  of latter  class  of medicines or  substances  was  essentially meant to cover only such medicines or substances which  were used  in the Ayurvedic or Unani system or were prepared  for use  in accordance with those systems.  In other  words  all medicines  or  substances had, under S. 16 of  the  Act,  to comply  with  the standard set out in the  Schedule,  as  it stood before the amendment made by Act XIII of 1964.  In the Schedule  classes of drugs and the standard which was to  be complied  with  were set out with reference  mostly  to  the standards  maintained at the National Institute for  Medical Research,  London and the standards of identity, purity  and strength  specified  in the (current edition  for  the  time being   of  the  British  Pharmacopoeia)  or   the   British Pharmaceutical Codex or any other prescribed  Pharmacopoeia, or  adopted  by  the  Permanent  Commission  on   Biological Standardisation  of the (World Health  Organisation).   Only one category consisting of medicines and substances used  or prepared   for  use  exclusively  in  accordance  with   the Ayurvedic  or Unani system of medicine was taken out of  the definition of drug before the amendments made by Act XIII of 1964.  That Act, as mentioned before, deleted the exception. In  our view medicines or substances have to be taken  as  a whole and in the present cases it will have to be decided by the trial magistrate whether Bindra’s Antiphlogistic Plaster and   Bindra’s  Yabrooj  Plaster  (Belladona  Plaster)   are medicines  which  are exclusively used or  which  have  been prepared   for  use  exclusively  in  accordance  with   the Ayurvedic  or  Unani  system of medicine.   As  regards  the adverb "exclusively" we concur in the view of the High Court that it must be taken to govern the words " used" as well as "prepared  for  use";  but in our  opinion  each  individual ingredient or component of the preparation in question  will not be the decisive or determining factor and what the court will have to decide after recording such evidence as may  be produced  will be whether the aforesaid medicines (they  can hardly  be called substances) were exclusively used or  were prepared   for  use  exclusively  in  accordance  with   the Ayurvedic  or Unani system.  If they fulfill that test  they would  be excluded from the definition of drug as  contained in  S.  3(b)(i).   With  these  observations,  however,  the appeals are dismissed.

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R.K.P.S. 227