Drugs Inspector & ANR. Vs.
Fizikem Laboratories Pvt. Ltd.& ANR. [2008] INSC 489 (24 March 2008)
A.K.Mathur & Altamas Kabir
(Arising out of S.L.P.(Crl.)No.5961 of 2006) A.K. Mathur, J.
1. Leave granted.
2. This appeal is directed against the order passed by learned Single Judge
of the Andhra Pradesh High Court in a batch of petitions under Section 482 of
the Code of Criminal Procedure (hereinafter to be referred to as the
CrPC) whereby the learned Single Judge has held that the Drugs Inspector appointed
under Section 21 of the Drugs and Cosmetics Act, 1940 (hereinafter to be
referred to as the Act) had no jurisdiction to launch prosecution
under Section 32 of the Act for alleged offences said to have been committed
under this Act in connection with manufacture and sale of Ayurvedic drugs
Ozomen capsules and Ozomen forte.
3. The brief facts which are necessary for disposal of this appeal are that
the Inspector of Drugs inspected some of the business premises of these
respondents where Ozomen capsules and Ozomen forte were available for sale. He
took the samples and after taking the sample he sent the same to the Government
Analyst, Hyderabad for analysis. The Government Analyst submitted his report
declaring that Ozomen capsules under different batches contained 45.2 mg of
sildenafil citrate per capsule. The persons from whom the samples were taken
were called upon to disclose the name of manufacturer and on disclosure of the
name of manufacturer, prosecution was launched against the respondents for
contravention of Sections 18), 18(a) (i) read with Section 17B(d) of the Act
namely, prohibition of manufacture and sale of certain drugs and cosmetics
which are misbranded, spurious and substituted wholly or in part by another
drug or substance and the Central Government prohibited manufacturer etc. of
the drugs and cosmetics in public interest under notification issued under
Section 26- A, vide notification No.GSR 577(e) dated 23.7.1983 punishable under
Sections 27(b)(ii), 27(c), 27(d) and 28-B of the Act. It is this action
initiated by the Drugs Inspector which was challenged. The respondents were
arrayed as accused for the aforesaid offences because they had no licence for
the manufacture of Ayurvedic drug sildenafil citrate and they were mislabeling
the Ayurvedic drugs. The sildenafil citrate is a new drug and it is patent and
proprietary medicine. It is an allopathic drug used for erectile dysfunction.
The respondent-accused company was holding Allopathic as well as Ayurvedic
licence but the company does not hold the licence to manufacture sildenafil
citrate. The information was received by the Drugs Inspector that sildenafil
citrate manufactured by these companies for various medical establishments in
the State of Andhra Pradesh had no licence to manufacture sildenafil citrate.
Ozomen forte capsule contained 33.9 mg to 46.82 mg of sildenafil citrate per
capsule. Therefore, the question was whether the respondent- company which are
manufacturing Ayurvedic drug and had no licence for manufacturing sildanefil
forte could be prosecuted under Chapter IV or not.
4. Before the Learned Single Judge it was submitted that since the
respondents are being prosecuted for contravention of Section 18, Section 19(a)
(i) read with section 17B (d) and Section 17(b) of the Act the accused had no
licence for manufacture of the sildenafil forte which is one of ingredient of
Ozomen forte i.e. Ayurvedic drug, therefore, the respondent can be prosecuted
under this section or not.
The submission of the respondents was that they have been holding licence
for the Ayurvedic preparation and for any Ayurvedic preparation of spurious or
misbranded nature, the Inspector appointed under Chapter IVA alone is competent
to launch prosecution and not Inspector appointed under Chapter IV.
5. In order to appreciate the contention raised by learned counsel for the
parties, it will be appropriate to refer to relevant provisions of the Act. The
Act defines Ayurveducm Siddha or Unani drug under Section 3(a) which reads as
under :
(a) Ayurvedic, Siddha or Unani drug includes all medicines
intended for internal or external use for or in the diagnosis, treatment,
mitigation or prevention of disease or disorder in human beings or animals, and
manufactured exclusively in accordance with the formulae described in, the
authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine,
specified in the First Schedule; Section 3(e) defines Inspector which
reads as under :
(e) Inspector means (i) in relation to Ayurvedic, Siddha or
Unani drug, an Inspector appointed by the Central Government or a State
Government under section 33G;
and (ii) in relation to any other drug or cosmetic, an Inspector appointed
by the Central Government or a State Government under section 21; Section
3(h) defines patent and proprietary medicine which reads as under:
(h) patent or proprietary medicine means,- (i) in relation to
Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations containing
only such ingredients mentioned in the formulae described in the authoritative
books of Ayurveda, Siddha or Unani Tibb systems of medicine specified in the
First Schedule, but does not include a medicine which is administered by
parenteral route and also a formulation included in the authoritative books as
specified in clause (a);
(ii) in relation to any other systems of medicine, a drug which is a remedy
or prescription presented in a form ready for internal or external
administration of human beings or animals and which is not included in the
edition of the Indian Pharmacopoeia for the time being or any other
Pharmacopoeia authorized in this behalf by the Central Government after
consultation with the Drugs Technical Advisory Board constituted under section
5; Section 13 deals with offences. Chapter IV deals with Manufacture, sale
and distribution of drugs and cosmetics. Section 16 under this Chapter deals
with standard and quality. As per Section 16, all drugs complies with the
standard set out in the second schedule. Section 17 deals with misbranded drugs
which reads as under:
17. Misbranded drugs.- For the purposes of this Chapter a drug shall
be deemed to be misbranded,- (a) if it is so coloured, coated, powered or
polished that damage is concealed or if it is made to appear or better or
greater therapeutic value than it really is;
or (b) if it is not labeled in the prescribed manner; or (c) if it is label
or container or anything accompanying the drug bears any statement, design or
device which makes any false claim for the drug or which is false or misleading
in any particular.
Section 17A deals with adulterated drugs which reads as under :
17A. Adulterated drugs- For the purposes of this Chapter, a drug shall
be deemed to be adulterated,- (a) if it consists in whole or in part, of any
filthy, putrid or decomposed substance; or (b) if it has been prepared, packed
or stored under insanitary conditions whereby it may have been contaminated
with filth or whereby it may have been rendered injurious to health; or (c) if
its container is composed, in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or (d) if it bears
or contains, for purposes of colouring only, a colour other than one which is
prescribed; or (e) if it contains any harmful or toxic substance which may
render it injurious to health; or (f) if any substance has been mixed therewith
so as to reduce its quality or strength. Section 17B deals with spurious
drugs, Section 17C deals with misbranded cosmetics and Section 17D deals with
spurious cosmetics. Section 18 which deals with prohibition of manufacture and
sale of certain drugs and cosmetics, is relevant for our purpose and reads as
under :
18. Prohibition of manufacture and sale of certain drugs and
cosmetics. From such date as may be fixed by the State Government by
notification in the Official Gazette in this behalf, no person shall himself or
by any other person on his behalf-
(a) manufacture for sale or for
distribution, or sell, or stock or exhibit or offer for sale, or distribute-
-
any drug which is not of a standard
quality, or is misbranded, adulterated or spurious;
-
any cosmetic which is not of a
standard quality or is misbranded or spurious;
-
any patent or proprietary medicine,
unless there is displayed in the prescribed manner on the label or container
thereof the true formula or list of active ingredients contained in it together
with the quantities, thereof;
-
any drug which by means of any
statement, design or device accompanying it or by any other means, purports or
claims to prevent, cure or mitigate any such disease or ailment, or to have any
such other effect as may be prescribed;
-
any cosmetic containing any
ingredient which may render it unsafe or harmful for use under the directions
indicated or recommended;
-
any drug or cosmetic in contravention of any of the provisions of this
Chapter or any rule made there under;
(b) sell, or stock or exhibit or offer for sale, or distribute any drug or
cosmetic which has been imported or manufactured in contravention of any of the
provisions of this Act or any rule made there under;
(c) manufacture for sale or for distribution, or sell, or stock or exhibit
or offer for sale, or distribute any drug or cosmetic, except under, and in
accordance with the conditions of, a licence issued for such purpose under this
Chapter;
Provided that nothing in this section shall apply to the manufacture,
subject to prescribed conditions, of small quantities of any drug for the
purpose of examination, test or analysis;
Provided further that the Central Government may, after consultation with
the Board, by notification in the Official Gazette, permit, subject to any
conditions specified in the notification, the manufacture for sale or for
distribution, sale, stocking or exhibiting or offering for sale or distribution
of any drug or class of drugs not being of standard quality. Section 18
prohibits any person from manufacturing for sale or for distribution or sell or
stock or exhibit or offer for sale or distribute any drug which is not of a
standard quality or is misbranded, adulterated or spurious. Section 18 ) says
that no person shall himself or by any other person on his behalf manufacture
for sale or for distribution, or sell or stock or exhibit or offer for sale or
distribute any drug or cosmetic, except under, and in accordance with the
conditions of, a licence issued for such purpose under this Chapter. Section 21
deals with Inspectors. The Inspectors can be appointed by the Central
Government or the State Government by notification in the Official Gazette
having the prescribed qualifications and they may perform such duties for drugs
or classes of drugs,or cosmetics or classes of cosmetics and they shall be
public servant within the meaning of Section 21 of the Indian Penal Code.
Section 22 lays down the powers of the Inspectors. The Inspector has power
to inspect any premises wherein any drug or cosmetic is being manufactured. He
has the power for testing the drugs or cosmetics. He has also power to search
and such other powers which are necessary for enforcement of the provisions of
the Act. Section 23 deals with procedure which is to be employed by the
Inspectors. After taking all necessary samples and obtaining report from the
Drugs Analyst he can also launch prosecution with the previous sanction.
Punishment has been prescribed under Section 27. Any person who manufactures
for himself or by any other person on his behalf, manufactures for sale or for
distribution, or sells or stocks or exhibits or offers for sale or distributes
any adulterated, spurious or misbranded drugs then he shall be punished under
Section 27. Chapter IVA which was introduced with effect from 1.2.1969 deals
with provisions relating to Ayurvedic, Siddha and Unani drugs. Here also
identical provisions are there. Section 33E deals with misbranded drugs,
Section 33 EE deals with adulterated drugs and Section 33EEA deals with
spurious drugs and it is punishable under Section 33-I. Section 33 G deals with
the Inspectors which says that the Central Government or a State Government
may, by notification in the Official Gazette, appoint such persons as it thinks
fit, having certain prescribed qualifications and it has laid down their
duties, functions who could launch prosecution for breach of any of the
provisions.
6. The provisions in Chapter IV and Chapter IVA are almost identical.
Chapter IVA deals with special branch of medicines like, Ayurvedic, Siddha and
Unani drugs whereas Chapter IV deals with branches other than Chapter IVA.
Learned Single Judge has taken the view that since Ozomen capsules had a
component like sildenafil citrate, therefore, they may be misbranded, spurious
or adulterated for which the prosecution could only be launched by the
Inspector authoricsed under Chapter IVA. But the prosecution in this case was
launched under Chapter IV. Therefore, learned Single Judge came to the
conclusion that the Inspector under Chapter IV had no jurisdiction to launch
the prosecution and it is only the Inspector who has been appointed under
Chapter IVA could have launched the prosecution against the accused for breach
of the provisions of the Act for adulteration, misbranding in the Ayurvedic
drugs.
7. Learned counsel for the appellants submitted that it is not the case that
only Chapter IVA is involved but the offence has also been committed under
Chapter IV also. Learned counsel for the appellants submitted that Ozomen
capsules and Ozomen forte had a component of sildenafil citrate and this
medicine does not fall under Chapter IVA.
Therefore, learned counsel for the appellants submitted that use of this
medicine in the Ayurvedic medicines is also punishable under Chapter IV as
accused has no licence to deal with this drug. The accused had to mix this drug
with other Ayurvedic drugs, therefore, the accused can also be prosecuted for
selling Allopathic drug like sildanefil citrate when licence is required under
Section 18. Learned counsel for the appellants submitted that sildenafil
citrate is a new drug and it is an Allopathic drug. This cannot be used for the
Ayurvedic medicines without displaying in the prescribed manner on the label or
container thereof or list of active ingredients contained in it together with
the quantities thereof.
It is also punishable under Section 18 (a)(iii) read with Section 27 (d) of
the Act. Learned counsel for the appellants also pointed out that the
respondents also manufactured and sold this spurious Ozomen capsules containing
sildenafil citrate violating section 18(a) which is punishable under Section
27(d) of the Act. The sum total of the submission of learned counsel for the
appellants was that the very fact of dealing with sildenafil citrate drug and
distributing the same after making a different component of Ayurvedic drug
itself constitutes an offence. Therefore, it is erroneous to say that since the
accused is dealing with Ayurvedic drugs therefore, only the Inspector who is
authorized under Chapter IVA could launch the prosecution and not the
Inspectors appointed under Chapter IV. The accused has used sildenafil citrate
which is an allopathic drug. Sildenafil citrate is a white to off-white
crystalline power with a solubility of 3.5 mg/ml in water and molecular weight
of 666.7 . Viagra (sildenafil citrate ) is formulated as blue, film-coated
rounded-diamond shaped tablets equivalent to 25mg, 50 mg and 100 mg of
sidenafil for oral administration. In addition to the active ingredient,
sildenafil citrate, each tablet contains the following inactive ingredients;
microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose
sodium, magnesium stearate, hypromellose, titanium dioxide,lactose, triacetin
and FD & C Blue No.2 aluminum lake. The brand name is Viagra and generic
name is sildenafil citrate. This is an allopathic drug and by no stretch of
imagination it can be said as an Ayurvedic drug. Therefore, learned counsel for
the appellants appears to be justified that since it is an allopathic drug and
it cannot be used by anybody else unless a person who holds the licence for it.
It is an admitted position that the accused does not possess the licence.
Therefore, the very fact of selling this drug as one of the ingredients in the
Ozomen capsule and not displaying the name in the prescribed manner in the
drugs will also constitute an offence under Section 18 (a), (b) & (c) punishable
under Section 27(b) (ii). The submission of learned counsel for the appellants
is justified and we are of opinion that the view taken by learned Single Judge
of the High Court is not correct and the High Court should not have proceeded
to quash the whole proceedings under Section 482 of the Code of Criminal
Procedure when serious issues were involved in the matter.
8. In the result, we allow this appeal and set aside the order passed by the
High Court and direct that the Inspector appointed under Chapter IV is
competent to launch prosecution for the aforesaid sections against the accused.
We have also been informed in the alternative prosecution has also been
launched against the accused under Chapter IVA. Both the prosecution can be
tagged together and the learned trial court should proceed with the matter.
However, any observations made by us in disposing this appeal will not
prejudice the rights of either parties.
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