Drugs and Cosmetics Act, 1940- Sections 8 to 15

Chapter III

IMPORT OF DRUGS [i][AND COSMETICS]

8. Standards of quality.

8. Standards of quality.—[ii][(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 [iii][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 [iv][the Second Schedule], for the purposes of this Chapter, and thereupon [v][the Second Schedule] shall be deemed to be amended accordingly.

9. Misbranded drugs.

[vi][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.]

9-A. Adulterated drugs.

[vii][9-A. 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.

9-B. Spurious drugs.

9-B. 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.

9-C. Misbranded cosmetics.

9-C. 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.

9-D. Spurious cosmetics.

9-D. 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 the product of a manufacturer of whom it is not truly a product.]

10. Prohibition of import of certain drugs or cosmetics.

10. Prohibition of import of certain drugs or cosmetics.—From such [viii]date as may be fixed by the Central Government by notification in the Official Gazette in this behalf, no person shall import—

(a) any drug [ix][or cosmetic] which is not of standard quality;

[x][(b) any misbranded drug or misbranded [xi][or spurious] cosmetic;]

[xii][(bb) any adulterated [xiii][or spurious] drug;]

(c) any drug [xiv][or cosmetic] for the import of which a licence is prescribed, otherwise than under, and in accordance with, such licence;

[xv][(d) 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 [xvi][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;

[xvii][(ee) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;]

(f) any drug [xviii][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 conditions, of small quantities of any drug for the purpose of examination, test or analysis 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.

Explanation.—[xix][* * *]

10-A. Power of Central Government to prohibit import of drugs and cosmetics in public interest.

[xx][10-A. 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.

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, 1878 (18 of 1878)[xxi] shall, subject to the provisions of Section 13 of this Act, apply in respect of drugs [xxii][and cosmetics] the import of which is prohibited under this Chapter, and officers of Customs and officers empowered under this Act to perform the duties imposed thereby on a [xxiii][Commissioner of Customs] and other officers of Customs, shall have the same powers in respect of such drugs [xxiv][and cosmetics] as they have for the time being in respect of such goods as aforesaid.

[xxv][(2) Without prejudice to the provisions of sub-section (1), the [xxvi][Commissioner of Customs] or any officer of the Government authorized by the Central Government in this behalf, may detain any imported package which he suspects to contain any drug [xxvii][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 package or sample of any suspected drug [xxviii][or cosmetic] found therein to the Central Drugs Laboratory.]

12. Power of Central Government to make rules.

12. Power of Central Government to make rules.—(1) The Central Government may, after consultation with [xxix][or on the recommendation of] the Board and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter:

[xxx][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 [xxxi][or cosmetics or classes of cosmetics] for the import of which a licence is required, and prescribe the form and conditions of such licences, the authority empowered to issue the same, the fees payable therefor [xxxii][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 [xxxiii][or cosmetic] is of standard quality;

(c) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation;

[xxxiv][(cc) prescribe under clause (d) of [xxxv][Section 9-A] 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 [xxxvi][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 for personal use;

(f) prescribe the places at which drugs [xxxvii][or cosmetics] may be imported, and prohibit their import at any other place;

(g) require the date of manufacture and the date of expiry of potency to be clearly and truly 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 [xxxviii][or cosmetics] for examination, test or analysis by the Central Drugs Laboratory, and prescribe 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 [xxxix][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 [xl][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 [xli][or cosmetics] imported for the purpose only of transport through, and export from, [xlii][India];

(k) prescribe the conditions to be observed in the packing in bottles, packages or other containers, of imported drugs [xliii][or cosmetics] [xliv][including the use of packing material which comes into direct contact with the drugs];

(l) regulate the mode of labelling drugs [xlv][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 [xlvi][or cosmetic or class of cosmetics.]

13. Offences.

[xlvii][13. Offences.—(1) Whoever himself or by any other person on his behalf imports,—

(a) any drug deemed to be adulterated under Section 9-A or deemed to be a spurious drug under Section 9-B or any spurious cosmetic referred to in Section 9-D 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 10-A, 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.

(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.

14. Confiscation.—Where any offence punishable under Section 13 has been committed, the consignment of the drugs [xlviii][or cosmetics] in respect of which the offence has been committed shall be liable to confiscation.

15. Jurisdiction.

15. Jurisdiction.—No court inferior to that [xlix][of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under Section 13.

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