Adulterated drugs

Section 33EE of the Drugs and Cosmetics Act and Rules deals with adulterated drugs. For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be adulterated,- (a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance;

For the purposes of this Chapter, an Ayurvedic, Siddha or Unani 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 coloring 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.

Explanation .- For the purpose of clause (a), a drug shall not be deemed to consist, in whole or in part, of any decomposed substance only by reason of the fact that such decomposed substance is the result of any natural decomposition of the drug:

Provided that such decomposition is not due to any negligence on the part of the manufacturer of the drug or the dealer thereof and that it does not render the drug injurious to health. 33EEA. Spurious drugs .- For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be spurious- (a) if it is sold, or offered or exhibited for sale, 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 any other drug or substance; or (e) if it purports to be the product of a manufacturer of whom it is not truly a product. 33EEB. Regulation of manufacture for sale of Ayurvedic, Siddha and Unani drugs .- No person shall manufacture for sale or for distribution any Ayurvedic, Siddha or Unani drug except in accordance with such standards, if any, as may be prescribed in relation to that drug. 33EEC. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drug .- From such date as the State Government may, by notification in the Official Gazette, specify in this behalf, no person, either by himself or by any other person on his behalf, shall- (a) manufacture for sale or for distribution- - (i) any misbranded, adulterated or spurious Ayurvedic, Siddha or Unani drugs;

(ii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true list of all the ingredients contained in it; and Drugs and Cosmetics Act, 1940 (iii) any Ayurvedic, Siddha or Unani drug in contravention of any of the provisions of this Chapter or any rule made thereunder;

(b) sell, stock or exhibit or offer for sale or distribute, any Ayurvedic, Siddha or Unani drug which has been manufactured in contravention of any of the provisions of this Act, or any rule made thereunder;

(c) manufacture for sale or for distribution, any Ayurvedic, Siddha or Unani drug, except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter by the prescribed authority:

Provided that nothing in this section apply to Vaidyas and Hakims who manufacture Ayurvedic, Siddha or Unani drug for the use of their own patients:

Provided further that nothing in this section shall apply to the manufacture, subject to the prescribed conditions, of small quantities of any Ayurvedic, Siddha or Unani drug for the purpose of examination, test or analysis. 33EED. Power of Central Government to prohibit manufacture, etc., of Ayurvedic, Siddha or Unani drugs in public interest .- Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied on the basis of any evidence or other material available before it that the use of any Ayruvedic, Siddha or Unani drug is likely to involve any risk to human beings or animals or that any such drug does not have the therapeutic value claimed or purported to be claimed for it 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 manufacture, sale or distribution of such drug.]

Section 33EE, The Drugs and Cosmetics Act and Rules (Act 23 of 1940).