Drugs and Cosmetics Act, 1940 - Standards of quality

16. Standards of quality.— [(1)(Note: Subs. by Act 21 of 1962, sec.12, for sub-section (1) (w.e.f. 27-7-1964)) 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 [the Second Schedule], and

(b) In relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.]

(2) The [(Note: Subs. by Act 11 of 1955, sec.8, for "State Government".) 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 [(Note: Subs. by Act 13 of 1964, sec.11, for "the Schedule" (w.e.f. 15-9-1964)) the Second Schedule] for the purposes of this Chapter, and thereupon [(Note: Subs. by Act 13 of 1964, sec.11, for "the Schedule" (w.e.f. 15-9-1964)) the Second Schedule] shall be deemed to be amended accordingly.

(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 labeled 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.

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 unsanitary 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.

17B. Spurious drugs. – For the purposes of this Chapter, a drug shall be deemed to be spurious, -

(a) If it is manufactured 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.

17C. 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 labeled 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.

17D. Spurious cosmetics. – For the purposes of this Chapter, a cosmetic shall be deemed to be spurious,-

(a) If it is manufactured under a name which belongs to another cosmetic ; or

(b) If it is an imitation of, or a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its 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.