8. Standards of quality.—5
[(1) For the purposes of this Chapter, the expression “standard quality”
means—
(a) in relation to a drug, that the drug complies with the standard set out in 6
[the Second
Schedule], and
(b) in relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.]
(2) The Central Government, after consultation with the Board and after giving by notification
in the Official Gazette not less than three months’ notice of its intention so to do, may by a like
notification add to or otherwise amend 6
[the Second Schedule], for the purposes of this Chapter,
and thereupon 6
[the Second Schedule] shall be deemed to be amended accordingly.
7
[9. Misbranded drugs.—For the purposes of this Chapter, a drug shall be deemed to be
misbranded—
(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to
appear of better or greater therapeutic value than it really is; or
(b) if it is not labelled in the prescribed manner; or
(c) if its 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.]
8
[9A. 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
1. Subs. by Act 3 of 1951, s. 3 and the Sch., for “the States”.
2. Ins. by Act 13 of 1964, s. 6 (w.e.f. 15-9-1964).
3. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983).
4. Subs. by s. 4, ibid., for the heading under Chapter III (w.e.f. 1-2-1983).
5. Subs. by Act 21 of 1962, s. 2, for sub-section (1) (w.e.f. 27-7-1964).
6. Subs. by Act 13 of 1964, s. 7, for “the Schedule” (w.e.f. 15-9-1964).
7. Subs. by Act 68 of 1982, s. 5, for section 9 (w.e.f. 1-2-1983).
8. Subs. by s. 6, ibid., for sections 9A and 9B (w.e.f. 1-2-1983).
10
(c) if its container is composed in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to hea lth; 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.
9B. Spurious drugs.—For the purposes of this Chapter, a drug shall be deemed to be
spurious—
(a) if it is imported under a name which belongs to another drug; or
(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in
a manner likely to deceive or bears upon it or upon its label or container the name of another
drug unless it is plainly and conspicuously marked so as to reveal its true character and its
lack of identity with such other drug; or
(c) if the label or container bears the name of an individual or company purporting to
be the manufacturer of the drug, which individual or company is fictitious or does not
exist; or
(d) if it has been substituted wholly or in part by another drug or substance; or
(e) if it purports to be the product of a manufacturer of whom it is not truly a product
9C. Misbranded cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed to be
misbranded—
(a) if it contains a colour which is not prescribed; or
(b) if it is not labelled in the prescribed manner; or
(c) if the label or container or anything accompanying the cosmetic bears any
statement which is false or misleading in any particular.
9D. Spurious cosmetics.—For the purposes of this Chapter, a cosmetic shall be deemed to be
spurious,—
(a) if it is imported under a name which belongs to another cosmetic; or
(b) if it is an imitation of, or is a substitute for, another cosmetic or resembles another
cosmetic in a manner likely to deceive or bears upon it or upon its label or container the
name of another cosmetic, unless it is plainly and conspicuously marked so as to reveal its
true character and its lack of identity with such other cosmetic; or
(c) if the label ,
or container bears the name of an individual or a company purporting to
be the manufacturer of the cosmetic which individual or company is fictitious or does not
exist; or
(d) if it purports to be product of a manufacture of whom it is not truly a product.]
10. Prohibition of import of certain drugs or cosmetics.—From such date1
as may be fixed
by the Central Government by notification in the Official Gazette in this behalf, no person shall
import—
1. 1st April, 1947, for cls. (a), (b), (c), (e) and (f) and 1st April, 1949, for cl. (d), see notification No. 18-12-46-D-I, dated the 11th
February, 1947, Gazette of India, 1947, Pt. I, p 189 as amended by notification No. F-1-2/48-D(I), dated the 29th September,
1948, 1st April, 1953, for the State of H.P., Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur vide notification
No. S.R.O. 666, dated the 30th March, 1953, Gazette of India, 1953, Pt. II, Sec. 3, p. 451.
11
(a) any drug 1
[or cosmetic] which is not of standard quality;
2
[(b) any misbranded drug 3
[or misbranded or spurious cosmetics];]
4
[(bb) any 5
[adulterated or spurious;] drug;]
(c) any drug 1
[or cosmetic] for the import of which a licence is prescribed, otherwise
than under, in accordance with, such licence;
6
[(d) any patent or proprietary medicine, unless there is displayed in the prescribed
manner on the label or container thereof 7
[the true formula or list of active ingredients contained in it together with the quantities thereof];]
(e) any drug which by means of any statement, design or device accompanying it or
by any other means, purports or claims to cure or mitigate any such disease or ailment,
or to have any such other effect, as may be prescribed;
1
[(ee) any cosmetic containing any ingredient which may render it unsafe or
harmful for use under the directions indicated or recommended;]
(f) any drug 1
[or cosmetic] the import of which is prohibited by rule made
under this Chapter :
Provided that nothing in this section shall apply to the import, subject to prescribed con -
ditions, of small quantities of any drug for the purpose of examination, test or ana lysis or for
personal use :
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 import of any drug or class of drugs not being of standard quality.
8
* * * * *
9
[10A. Power of Central Government to prohibit import of drugs and cosmetics in
public interest.—Without prejudice to any other provision contained in this Chapter, if the
Central Government is satisfied that the use of any drug or cosmetic is likely to involve any
risk to human beings or animals or that any drug does not have the therapeutic value claimed
for it or contains ingredients and in such quantity for which there is no therapeutic justification
and that in the public interest it is necessary or expedient so to do then, that Government may,
by notification in the Official Gazette, prohibit the import of such drug or cosmetic.]
11. Application of law relating to sea customs and powers of Customs officers.—(1) The
law for the time being in force relating to sea customs and to goods, the import of which is prohibited by section 18 of the Sea Customs Act, 187810 (18 of 1878) shall, subject to the provisions
of section 13 of this Act, apply in respect of drugs 11[and cosmetics] the import of which is
prohibited under this Chapter and officers of Customs and officers empowered under that Act
to perform the duties imposed thereby on a 12[Commissioner of Customs] and other officers of
1. Ins. by Act 21 of 1962, s. 8 (w.e.f. 27-7-1964).
2. Subs. by s. 8, ibid., for clause (b) (w.e.f. 27-7-1964).
3. Subs. by Act 68 of 1982, s. 7, for “or misbranded cosmetic” (w.e.f. 1-2-1983).
4. Ins. by Act 13 of 1964, s. 9 (w.e.f. 15-9-1964).
5. Subs, by Act 68 of 1982; s. 7, for “adulterated” (w.e.f. 1-2-1983).
6. Subs. by Act 11 of 1955, s. 5, for clause (d).
7. Subs. by Act 68 of 1982, s. 7, for certain words (w.e.f. 1-2-1983).
8. The Explanation omitted by Act 68 of 1982, s. 7 (w.e.f. 1-2-1983).
9. Ins. by s. 8, ibid. (w.e.f. 1-2-1983).
10. Now see the Customs Act, 1962.
11. Ins. by Act 21 of 1962, s. 9 (w.e.f. 27-7-1964).
12. Subs. by Act 22 of 1995, s. 83, for “Customs Collector”.
12
Customs, shall have the same powers in respect of such drugs 1
[and cosmetics] as they have for the time
being in respect of such goods as aforesaid.
2
[(2) Without prejudice to the provisions of sub-section (1), the 3
[Commissioner of
Customs] or any officer of the Government authorised by the Central Government in this
behalf, may detain any imported package which he suspects to contain any drug 1
[or
cosmetic] the import of which is prohibited under this Chapter and shall forthwith report
such detention to the Drugs Controller, India and, if necessary, forward the p ackage or
sample of any suspected drug 1
[or cosmetic] found therein to the Central Drugs Laboratory.]
12. Power of Central Government to make rules. —(1) The Central Government may,
4
[after consultation with or on the recommendation of the Board] and after previous publication
publication by notification in the Official Gazette, make rules for the purpose of giving effect
to the provisions of this Chapter :
5
[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 the 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—
(a) specify the drugs or classes of drugs 6
[or cosmetics or classes of cosmetics] for the
import of which a licence is required, 7
[and prescribed the form and conditions of such
licences, the authority empowered to issue the same, the fees payable therefor and provide
for the cancellation, or suspension of such licence in any case where any provision of this
Chapter or the rules made thereunder is contravened or any of the conditions subject to
which the licence is issued is not complied with] ;
(b) prescribe the methods of test or analysis to be employed in determining whether a drug
6
[or cosmetic] is of standard quality ;
(c) prescribe, in respect of biological and organometallic compounds, the units or methods of
standardisation;
8
[(cc) prescribe under clause (d) of 9
[section 9A] the colour or colours which a drug
may bear or contain for purposes of colouring;]
(d) specify the diseases or ailments which an imported drug may not purport or claim
10[to prevent, cure or mitigate] and such other effects which such drug may not purport or
claim to have;
(e) prescribe the conditions subject to which small quantities of drugs, the import of
which is otherwise prohibited under this Chapter, may be imported for the purpose of
examination, test or analysis or for personal use;
(f) prescribe the places at which drugs 6
[or cosmetics] may be imported, and prohibited their
import at any other place;
1. Ins. by Act 21 of 1962, s. 9 (w.e.f. 27-7-1964).
2. Subs. by Act 11 of 1955, s. 6, for sub-section (2).
3. Subs. by Act 22 of 1995, s. 83, for “Customs Collector”.
4. Subs. by Act 68 of 1982, s. 9, for “after consultation with the Board” (w.e.f. 1-2-1983).
5. Ins. by Act 11 of 1955, s. 7.
6. Ins. by Act 21 of 1962, s. 10 (w.e.f. 27-7-1964).
7. Subs. by Act 68 of 1982, s. 9, for certain words (w.e.f. 1-2-1983).
8. Ins. by Act 13 of 1964, s. 10 (w.e.f. 15-9-1964).
9. Subs. by Act 68 of 1982, s. 9, for “section 9B” (w.e.f. 1-2-1983).
10. Subs. by Act 11 of 1955, s. 7 for “to cure or mitigate”.
13
(g) require the date of manufacture and the date of expiry of potency to be clearly and
truely stated on the label or container of any specified imported drug or class of such drug,
and prohibit the import of the said drug or class of drug after the expiry of a specified period
from the date of manufacture;
(h) regulate the submission by importers, and the securing, of samples of drugs
1
[or cosmetics] for examination, test or analysis by the Central Drugs Laboratory, and
prescribed the fees, if any, payable for such examination, test or analysis;
(i) prescribe the evidence to be supplied, whether by accompanying documents or
otherwise, of the quality of drugs 1
[or cosmetics] sought to be imported, the procedure of
officers of Customs in dealing with such evidence, and the manner of storage at places of
import of drugs l
[or cosmetics] detained pending admission;
(j) provide for the exemption, conditionally or otherwise, from all or any of the provisions
of this Chapter and the rules made thereunder of drugs 1
[or cosmetics] imported for the
purpose only of transport through, and export from, 2
[India];
(k) prescribe the conditions to be observed in the packing in bottles, packages or other
containers, of imported drugs 1
[or cosmetics] 3
[including the use of packing material which comes
into direct contact with the drugs];
(l) regulate the mode of labelling drugs 1
[or cosmetics] imported for sale in packages, and
prescribe the matters which shall or shall not be included in such labels;
(m) prescribe the maximum proportion of any poisonous substance which may be added
to or contained in any imported drug, prohibit the import of any drug in which that proportion
is exceeded, and specify substances which shall be deemed to be poisonous for the purposes
of this Chapter and the rules made thereunder;
(n) require that the accepted scientific name of any specified drug shall be displayed in the
prescribed manner on the label or wrapper of any imported, patent or proprietary medicine
containing such drug ;
(o) provide for the exemption, conditionally or otherwise, from all or any of the provisions of
this Chapter or the rules made thereunder of any specified drug or class of drugs l
[or cosmetics or
class of cosmetics].
4
[13. Offenees.—(1) Whoever himself or by any other person on his behalf imports,—
(a) any drug deemed to be adulterated under section 9A or deemed to be a spurious drug
under section 9B or any spurious cosmetic referred to in section 9D or any cosmetic of the
nature referred to in clause (ee) of section 10 shall be punishable with imprisonment for a term
which may extend to three years and a fine which may extend to five thousand rupees;
(b) any drug or cosmetic other than a drug or cosmetic referred to in clause (a), the
import of which is prohibited under section 10, or any rule made under this Chapter, shall be
punishable with imprisonment for a term which may extend to six months, or with fine which
may extend to five hundred rupees, or with both;
(c) any drug or cosmetic in contravention of the provisions of any notification issued under
section 10A, shall be punishable with imprisonment for a term which may extend to three
years, or with fine which may extend to five thousand rupees, or with both.
1. Ins. by Act 21 of 1962, s. 10 (w.e.f. 27-7-1964).
2. Subs. by Act 3 of 1951, s. 3 and Sch., for “the States”.
3. Ins. by Act 68 of 1982, s. 9 (w.e.f. 1-2-1983).
4. Subs. by s. 10, ibid., for section 13 (w.e.f. 1-2-1983).
14
(2) Whoever having been convicted of an offence—
(a) under clause (a) or clause (c) of sub-section (1), is again convicted of an offence
under that clause, shall be punishable with imprisonment for a term which may extend to
five years, or with fine which may extend to ten thousand rupees, or with both;
(b) under clause (b) of sub-section (1), is again convicted of an offence under that
clause, shall be punishable with imprisonment for a term which may extend to one year,
or with fine which may extend to one thousand rupees, or with both.
(3) The punishment provided by this section shall be in addition to any penalty to which
the offender may be liable under the provisions of section 11.]
14. Confiscation.—Where any offence punishable under section 13 has been committed, the
consignment of the drugs 1
[or cosmetics] in respect of which the offence has been committed shall be
liable to confiscation.
15. Jurisdiction.—No Court inferior to that 2
[of a Metropolitan Magistrate or of a Judicial Magistrate
of the first class] shall try an offence punishable under section 13.