COSMETICS RULES 2020
Authored by Ammu Brigit
We all recognise cosmetics as any products used on or applied to human body with the intention of personal care and beautification. The manufacture, distribution and import of cosmetics in India is governed by Drugs and Cosmetics Act 1940(DCA). The Ministry of Health and Family Welfare (MoHFW) has notified the Cosmetics Rules 2020 (“Rules”) which apply to the import, manufacture for sale or for distribution of cosmetics.
Summary of the Rules
The Rules are divided into nine chapter, thirteen schedules and appendixes containing the formats of the forms required for the registration under DCA. The Rules determines the licensing authorities with respect to cosmetics and also provides for the constitution of central cosmetics laboratory. The Rules also comprehensively sets out the procedure for the registration for the import of cosmetics, manufacture of cosmetics for sale and distribution, permission of sale or manufacture of a new cosmetic in India, standards in relation to labelling, packing of cosmetics for the sale and distribution of cosmetics, procedure for sampling of tests of analysis, seizure and report and approval of laboratory for carrying out test in cosmetics and raw materials.
Highlights of the Rules.
Licensing Authority
The Drug Controller General of India (DGCI) is the central licensing authority responsible for the import of all categories of cosmetics and also the coordination with state authorities. The state drug controller of the respective state shall be the state licensing authority and shall be responsible for manufacture for sale or distribution, sale, stock, exhibit or offer for sale or distribution of all categories of cosmetics and for granting of approval of to the laboratory for carrying out tests on cosmetics and their raw materials.
Constitution of Central Cosmetic Laboratory
The Rules provides for the constitution of Central Cosmetic Laboratory for analysing and testing of samples sent. The Rules also give power to the Central Government to designate or notify any laboratory which is duly accredited by National Accreditation Body for Testing and Calibration Laboratories as a central cosmetic laboratory for carrying out tests and evaluation of cosmetics.
Import, Manufacture for Sale or for Distribution
A cosmetic product can be manufactured or imported to India only after the obtaining the license from the respective licensing authority with the required document and paying the required fees. For the manufacturing of cosmetic products, a license has to be sought from the respective state licensing authority and for import of cosmetics to India, the licensing authority is DGCI.
Labelling and Packing Standards
The Rules prohibits the selling or distribution of any cosmetic of Indian origin unless it is manufactured by a licensed manufacturer and labelled and packed according to the conditions given under the Rules and also false and misleading claims on cosmetic products. The Rules principally lays out the manner of labelling and packaging and also the standards if cosmetics imported.
Conclusion
Effective from 15th December 2020, the intention of the new Rules is to revise and codify separately the rules pertaining to the import, manufacture for sale or for distribution of cosmetics in India and have accordingly amended the provisions in Drugs and Cosmetics Rules 1945 (DCR) to omit cosmetics from the purview of DCR.