ISHWAR SINGH BINDRA & ORS. versus THE STATE OF U.P.

ISHW AR SINGH BINDRA & ORS.

THE STATE OF U.P.

May 2, 1968

[M. HIDAYATULLAH, C.J., C. A. VAIDIALINGAM AND A. N. GROVER, JJ.]

Drugs Act, 1940 s. 3(b) (i)-Definition of 'drug'-Scope of-Medi· cines and substances used or prepared for use in accordance with Ayur ... vedic or Unanl systen1s-When excluded.

The Inspector of Drugs, Agra Region, filed complaint in July 1963 be, fore Magistrate at Mathura alleging preparation called anti-pblogistic plaster was manufactured and soid by firm of which the first two appellants wero 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 maimfacturing 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 he deemed to be 'misbranded'. Moreover the label of the plaster showed that it was 'a Unani preparation which was apparently false and misleading claim. Accordingly, it was alleged that offences bad been committed under s. 18(a)(ii) read with ss. 27(a) and (b) of the Act for selling mis-branded drug 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 bad been manufactured without licence required for the purpose under the Act.

The appellants filed petition under s. 561A of the Criminal Pro-cedure Olde in the High Court in March 1964 and claimed int.r alia that the plaster was not 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 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 Unani 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 dntg such medicines and substances which were used exclusively in accordance with the A)rurvedic 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 lo 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 or sub· st~11c~s with \h~ ('XCeption of such m~~ici11cs or subst~nces whicb i1f~

exclusively used or preporcd for u>c ia accordance with the AyurVcdic or Unani system of medicines. The exception made in the ca~c of the latter cJ;iss of medicines or suhstances \\'as essentially meant to cover only such medicines or substances \Vhich y,·cre used in the Ayurvedic or Unani system or \Vere prepared for use in accordance with those systems. [226 A.:.....Bl Medicines or_ sub~tanccs have to be taken as who1e and in the pre~ sent cases it would h.wc to be decided by the trial court whether the plasters in question arc mc<llcines ''·hich arc exclusively uo::cd or v.·hich have been prepared for use cxcJusivcly in accordance with the Ayur-vedic or Gnani system of medicine. The High Court was ris:ht in its view that the adverb "excl11sivcly" must he taken to govern the words "used" as \&.'ell as "prepared for use"; but each individual in~edicnt or component· of the prepJration in question will not be the decisive or detCTinining factor and what the court will have to decide after recording such evidence as mav be produced will be whether the plasters sotisfy the above tO't. If thev fulfil that test thev would be excluded from the definition of dru.g os contained in s. 3(b)(i). [226 E---0)

Chimmi/a/ Jagjivmulas Sheth v. Stair of Maharashtra, (1963) Supp. I S.C.R. 3.44; Stroud's Judicial Dicrioiuiry 3rd Ed. 135 and Maxwe!/ 011 Interpretation of Statutes, I Ith Ed. referred to.

CRIMll'AL APPEi.LATE JuRISDICTION : Criminal Appeals Nos. 190 and 191 of 1965.

Appeals from the judgment and order, dated July 20, 1965 of the Allahabad High Court in Criminal Mis. Cases Nos. 562 and 563 of 1964.

Bishan Narain and Harbans Singh, for the appellants.

G. N. Dikshit and 0. P. Rana, for the respondents.

The Judgment of the Court was delivered by

Grover, J.-Thesc are two companion aopeals by certificates

from the judgment of the High Court of Judicature at Allahabad dismissing two peti•ions under s. 56!A of the Criminal Procedure Code. in which the sole question raised rela•ed 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 (Amend-ment) Act 1964 (Act XIIT of 1964).

As the po;nt involved is common to both the appeals .the facts in Cr. Appeal No. 190 of 1965 may be shortly stated. The first two appellants arc 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 tlyurvedic and Unani systems of medicines at Delhi, Shah-dara. The Inspector of Drugs, Agra Region, filed complaint dated July 2, 1963 in the court of Magis•rate, First Class. at Mathura alleging inrer alia that on September 20, 1962 when he was carryi°ng out the inspection of th.e shop of Mis Frontier Gupta Medical Stores. Mathura. he came across preparation

I. s. BJNDRA I', STATE OF U.P. (Grover, !.)

called Antiphlogistic Plaster manufactured by the aforesaid Cor-poration. On examining the label it was discovered that although the names of three drugs i.e. Glycerine, Kaolin and Boric Acid which are to be found in Pharmacepoeias prescribed under the Act were mentioned as constituents of the plaster, the label did not bear manufacturing Licence Number and other particulars with which drug was required to be labelled in accordance with Rule-96 of the Drug Rules 1945. According to the Inspec-tor 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 Unani preparation which was apparently false and misleading claim. ·A sample was sent to the Government Analyst who gave 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 mis-branded 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, drug "misbranded" as per s. 17(f) ands. 17(e) respectively of the Act and under s. 18(b) read withs. 27(b) of the Act for selling the same drug which had been manufactured without licence re-quired for the purpose under the Act, to M/s Frontier Gupta Medical Stores, Mathura.

On March 24, 1964 the appellants filed petition under s. 561A of the Code in the High Court raising number of points including the question of the jurisdiction of the Court at Mathura to entertain the complaint as also that the Antiphlogistic Plaster was not drug as defined in the Aet and praying that the entire proceedings pursuant to the complaint be quashed. In the affi-davit accompanying the petition it was stated that the ingredients used in the prepara•ion of Bindra's Antiphlogistic Plaster were in accordance with the Unani system of medicine. These ingre-dients 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 drug when the whole preparation itself was an Ayurvedic medicine. Reference was made to certain books like Ramooz-Ul-Taba, Kitabul Davaiva and Kaniz-Ul-Taba which were well known books of the Unani svstem of medicine in wh;ch Glycerine and Boric were recognised as medicines used in that sys•em. The other componentS of the plaster were, it is stated, of Unani origin and frequently used for preparations in accordance with Ayurve-

die and Unani system. The Inspector of Drugs filed counter affidavit in which it was pointed out that Glycerine, Kaolin and Boric Acid were drugs which were to be found in tbe British Pharmaceutical Codex 1958. The "monographs" of Glycerine. heavy Kaolin. light Kaolin and Boric Acid containing the for-mulae 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 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 Antiphlo-gistic Plaster and those were medicines which were not exclusively used in accordance with either the Ayurvedic or the Unani syslem of medicine. In the further affidavit filed by the appellants it was maintained that Glvcerine 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 preparation made accord-ing to the Ayurvcdic system. It was pointed out that the medi-cine known as Kaolin Poultice was entirely different from Bindra's Antiphlogistic Plaster.

The definition of "drug" contained ins. 3(b) is in the follow-ing terms :-

"(i) all medicines for internal or external use of human beings or animals and all substances in-tended to be used for or (in the diagnosis, treat-ment), mitigation or prevention of disease in human beings -or animals other than medicines and substances exclusively used or prepared for use in accordance with Avurvedic 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 or intended to intended to be used for the des-G

(ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to or intended to intended to be used for the des-truction of vermin or insects which cause disease in human bein~s or animals, as may specified from time to time by the Central G-ov-crnment by notification in the Official Gazette."

The contention of the appellants before the High Court was that in the ]a st part of cl. ( i) the adverb "exclusively" governed the n word "used" only and did not govern the words "prepared for use". The other argument raised was that the legislature in-tended to except from the definition of drug medicines and S\lb-

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 U_nam 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 dis-puted questions of fact as to whether Bindra's Antiphlogistic plaster fell within the exception and was not drug and observed that the question as to whether medicine or substance was used exclusively or prepared for use exclusively in accordance with the Ayurdcvic or Unani system of medicine was question of fact, the decision of which would hinge inter alia on expert evidence.

It has been urged by Mr. Bishan Narain that on true inter-

pretation of the words embodying the exception 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. w.hich are used in the Allopathic system as also in the Ayurvedic or Unani systems. By way of il'lustration, in the Unani system fat was being used in pr.eparation 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, t]).at the Government Analyst to whom the sample of the ?,laster was sent, was not qualified and indeed could not be qualified to ·ex-F press 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 Bri?sh Phai;mic~utical .Code~ ~ave been employed in the prepa· ration of Bmdra s. Antiphlo,g1stic Pla~ter .. It is strenuously con· tended 0at ~y s1!11ple de':'ice of callmg .1t Unani or Ayurvedic preparation m which adnuttedly Glycenne Kaolin Boric Acid etc. have been used, which find place in B;itish Pharmaceutical Codex and are clearly drugs, the appellants carmot escape the consequences of infringement of the provisions of the Act.

At this S!<I;ge it would be useful to refer to some of the im-H portant proVIsions of ~e ~ct.. It was enacted to regulate the ~port, manufactur~,, ~stnbution and sale of drugs. The defi-mtion of drug as give~ m s. 3 (b) was made as wide as it could be and the only exception related to the medicines and substances

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 express.on "standard quality" when applied to drug means that the drug complies with the standard set out in the Schedule. Section 17 relates to misbranded drugs. Section 18 prohibi:s manufacture and sale of sub-standard drugs includ.ng misbranded drugs. Sec-tions 20 & 21 provide for the appoin:ment 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.

nwnber of amendments were made by Act Xlll 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. (i) the words "other than medicines and sub-stances exclusively used or prepared for use in accordance with the Ayurvedic or Unani system of medicine" were deleted. Before clal!se ( aa) the following clause was inserted : (a) "Ayurvedic (including Siddha) or Unani drug" includes all medicines intended for internal or external use for or in the diagnosis, treatment mitigation or prevention of disease in hwnan beings, mentioned in, and processed and manufactured exclusively in accord-ance 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 Ayur-vedic 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 s:i.lc, or distribute, any Ayurvedic (including Siddha) or Unani drug other than that manufactured by manufacturer licensed under this Chapter. Penalties w~rc provided for the infringement of the provisions contained in the Chapter.

There can be no difficulty now after the amendments made by Act XIll of 1964 in the matter of medicines and substances exclusively used or prepared for use in accordance with the Ayur-vcdic or Unani system of medicine provided they arc processed and manufactured according to the fom1ulae described in the authoritative books as specified in the First Scb~dulc. The diffi-culty, however, remains with regard to the true import of the

I. s. BINDRA V, STATE OF U.P. (Grover, .T.)

exception in the definition of "drug" in the Act. In Chimanlal Jagjivandas Sheth v. State of Maharashira([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 furn of repute at Secunderabad. The Government Analyst had reported that only the lint was of stand-ard quality and the other articles were not of standard quality. He had been convicted and sentenced to undergo rigorous im-prisonment for three months ati.d to pay 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 comprehen_sive enough to take in not only !Ilf'.,dicines but also substances intended fo be used for or in the treatment of diseases of human beings or animals. This artificial definition introduces distinction between medicines and sub-stances which are not medicines strictly so called. The expression 'substances', therefore, must be something other than medicines but which are used for treatment."

The dict;ionary 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 of "substance" relevant for our purposes is "any particular kind of corporeal matter-a species of matter of definite chemical com-position-a piece or mass of particular kind of matter-a body of specified composition or texture."

.F Now if the expression "substances" is to be. taken to mean 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 con-·G text to read it disjunctively. In Stroud's Judicial Dictionary, 3rd Ed. it is stated at page 135 that "and" has generally cumu-lative sense, requiring the fulfilment of all the conditions that it joins together, and herein it is the antithesis of "or". Sometimes, however, even in such connection, it is, by force of context, read as "or". Similarly in MaxweII 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".The scheme of cl. (i) of s. 3(b) apparently is to take in all medicines or substances with the exception of such mcdicin~s or substances which arc r~xclusively 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 sub-stances was csscnti;11ly meant to cover only such medicines or substances which were used in the Ayurvcdic or Unani system or were prepared for use in accordance with those systems. In other words all medicines or substances had. under s. J 6 of the Act, to comply with the standard sci 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 lo be c:>m-plied with were set out with reference mostly to the standards maintained at the National lnslitutc for Medical Research. London and the standards of identity. purity and str:~ngth speci-fied !n the (current edition for the time being of the British Phar-macopoeia) or the Brilish Pharmaceutical Codex 0r any other prescribed pharmacopoeia. or adopted by the Permanent C<>n1-mission on Biological Standardisation of the (World Health Or-µanisation). Only one category consist in;; of medicines and sub-D stances used or prepared for use exclusively in accnrdanc!.: wi1Ji the Ayurvcdic or llnani system o[ medicine was taken out of the definition of drug bcforn the amendments made by Act XIII or 1964. 1liat Act, as mentioned before, deleted the exception.

Jn our view mcdicin.zs or substances have to be taken as whole and in the present cases it will have to be decided by the F. trial magistrate whether Bindra·s Antiphlogistic Plaster and Bindra's Yabroo.i Plaster (Hclladona Plaster) arc medicines wi1ich are exclusively used or which have been prepared for use -:x-clusively in accordance with the Ayurvcdic or Unani system or medicine. As regards the adverb "exclmivcly" we concur in the view of the Hi.~h Court tha1 it must be taken 10 govern the words "used'' as well as "prepared for use": but in our opinion each individual ingredient or component of the preparation in c;ucs-tion will not be the decisive or determinin)! factor and wh;1t the court will have to decide aflcr recording such evidence as may be produced will be whether the aforesaid medicines (they can hardly be called sub,tanccs) were exclusively used or were pre-r;1rcd for use .exclusivch in accordance with the Avurvcdic or IJnani system. If they fulfil that test they would be ex~ludcd from the definition of druc as contained in s. 3(b)(i). With the,;e obscrv;1tions. howevei·: the appeals arc dismissed.

R.KP.S.