Drugs and Cosmetics Act, 1940 has been enacted to regulate the import, manufacture, sale and distribution of drugs and cosmetics. The main object of the Act is to ensure availability of standard quality cosmetics to the consumer.
Law is need base. Like every law the Drugs and Cosmetics Act has been enacted because the situation demanded for such legislation and has also undergone changes to meet the challenges posed by the ever changing scenario.
The instances of contact dermatitis because of use of deodorants, pomades, lipsticks and nail polishes, the risk of cumulative toxicity of azo and other synthetic dyes used in the manufacture of lipsticks, etc. and lack of even elementary precautions for testing raw materials and observing hygienic condition during manufacture by the units dispersed throughout the country prompted the Government of India to consider measures to regulate control over the manufacture of the cosmetics.
The issue was discussed at the meeting of the Central Council of Health Held at Jaipur in October 1960. The consensus of opinion was that the manufacture of cosmetics should be regulated, if necessary, by extending the provisions of the Drugs Act, 1940, to them. The Drugs Act, 1940, was therefore suitably amended so as to provide for regulation of the manufacture of cosmetics and prohibition of import and sale of sub-standard and misbranded cosmetics. 4[Based on the Statement of Object of Act 21 of 1962].
Definition of Cosmetics as under Section 3 (aaa) – Legislative background
Definition of ‘cosmetic’ has been inserted in principal Act (23 of 1940) by Section 4 of Act 21 of 1962 as clause (aa) in Section 3 of the Act. The said clause (aa) was relettered as clause (aaa) by Section 2 of Act 13 of 1964 when clause (a) defining Ayurvedic or Unani drug was inserted in said Section 3.
Scope of the definition of cosmetics widened
In order to exercise control over toilet soaps which may contain harmful ingredients like hexachlorophene, the scope of the definition of the ‘cosmetic’ has been widened by the Section 3 of the amending Act. 68 of 1982. By virtue of this amendment, the words “but does not include soap” have been deleted from definition of the cosmetics. As a result of the said amendment “toilet soaps” have been brought within the scope of definition of “cosmetic”. 34[Based on the statement of objects of Act 68 of 1982]
12[13[(aaa)] “cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic, 14 [***];]
17-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.
17-D. 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 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 manufacturer of whom it is not truly a product.]
18. Prohibition of manufacture and sale of cosmetics.—
From such 10date 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 11[or for distribution], or sell, or stock or exhibit 11[or offer] for sale, or distribute—
(ii) any cosmetic which is not of a standard quality or is misbranded or spurious;]
1316[(v) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended;
(vi) any drug or cosmetic in contravention of any of the provisions of this Chapter or any rule made thereunder;]
(b) sell, or stock or exhibit 17[or offer] for sale, or distribute any drug 18[or cosmetic] which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made thereunder;
(c) manufacture for sale 17[or for distribution] or sell, or stock or exhibit 17[or offer] for sale, or distribute any drug 18[or cosmetic], except under and in accordance with the conditions of a, licence issued for such purpose under this Chapter :
27-A,. Penalty for manufacturer, sale, etc., of cosmetics in contravention of this Chapter.—Whoever, 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,--
(i) any cosmetics deemed to be spurious under Section 17-C shall be punishable with imprisonment for a term which may extend to three yearsand with fine . (
(ii) any cosmetic other than a cosmetic refered to clause (i) above in contravention of any provision of this chapter or any rule made thereafter shall be punishable with imprisonment for a term which may extend to one year or with which may extend to one thousand rupees or with both.
Licensing of Cosmetics
Provisions for grant of a licence to manufacture cosmetics is given in Part XIV, rules 137 to 143 of the Drugs and Cosmetics Rules, 1945.
1 For obtaining own licence an application in Form 31 is required to be made along with requisite fee. The amount of fee to be paid has been tabulated and is enclosed (Appendix A).
2 The requirement for manufacturing area, machinery and technical personnel shall be as per the provisions of Rule 139 read with Schedule M II
[See Rule 139]
REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF COSMETICS