Cosmetics in US and India: Overview of Regulations and Registration process
Cosmetics, for a long period of time have been used as beauty products for the care of body and face which eventually enhances a person’s appearance. These products are usually constituted from a mixture of different chemical compounds which are synthetic as well as organic in nature. For a long period of time, these products have not come under the ambit of regulatory authorities and have gone through the markets unchecked. The way a drug manufacturing and sale process is monitored by the regulatory authorities across the world, which includes careful monitoring of clinical trials, scrutinizing research results like safety, efficacy and quality of a drug has been avoided for a long period of time in case of parameters related to cosmetics. Some groups alleged that the industry practices are flawed, that there is little government regulation, and that cosmetics contain cancer-causing chemicals and other toxicants which are harmful for human body. Rules have certainly changed over time and major countries like India have started following guidelines while giving regulatory approval to cosmetics just like USA. The U.S. (FDA) functions include the banning and restriction of ingredients for safety purposes. The Cosmetic Ingredient Review (CIR) which is an independent review board that critically evaluates chemical ingredients used in cosmetics and publishes results of its findings. Similarly in India, CDSCO (Central Drugs Standard Control Organisation) and DCGI (Drug Controller General Of India), both are responsible for evaluating the composition of cosmetic products and their safety while referring to a drafted set of guidelines known as BIS( Bureau of Indian standards) guidelines. The article focuses on various aspects considered by USA and India while giving regulatory approval to cosmetic products.
2. Draelos ZD. Cosmetics: The Medicine of Beauty. Journal of Cosmetic Dermatology. 2015;14 (2):91
3. Gerberick, G. F, and Robinson. M.K. A skin sensitization risk assessment approach for evaluation of new ingredients and products. Am. J. Contact Dermatitis. 2000;11:65–73.
4. Gerberick, G. F., Robinson.M.K and Stotts. J. An approach to allergic contact sensitization risk assessment of new chemicals and product ingredients. Am. J. Contact Dermatitis. 1993; 4:205-211.
5. Robinson. M. K., Stotts.J, Danneman.P.J and Nusair.T.L. A risk assessment process for allergic contact sensitization. Food Chem. Toxicol. 1989; 27:479-489.
6. CFSAN/Office of Cosmetics and Colors. FDA Authority over Cosmetics. CFSAN [Internet].US FDA; 2005 [cited 2020 Aug 03]. Available from:
7. 21 CFR Volume 17, 2002. Code of Federal Regulations, Title 21, Volume 7. Chapter 1-Food and Drug Administration. Department of Health and Human Services. Subpart B-Requirements for Specific Cosmetic Products; 2002
8. Cosmetic Ingredient Review: General Information. Accessed [Internet]. CIR;2005 [cited 2020 Aug.03]. Available from:
9. Drugs & Cosmetics Act 1940 [Internet]. CDSCO; 1940 [cited 2020 Apr.10]. Available from:
10. Shaik Md. ZH, Shiva J, Venkateswarlu G, Suthakaran R, Ghouse S. Intellectual Property Right in India- A Review. Int J Drug Reg Affairs [Internet]. 2019 Sep.17 [cited 2020 Sept.22]; 7(3):8-13. Available from:
11. Saddik P, Pappan J. Differentiation between the Regulatory paths placed on Mouthwashes in the US and EU. Int J Drug Reg Affairs [Internet]. 2018 Jun.15 [cited 2020 Sept.21]; 6(2):8-13. Available from:
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM