REGULATORY PROTOTYPE FOR COSMETICS IN INDIA

  • NAGALAKSHMI S Department of Pharmaceutics, Sri Ramachandra Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research (DU), Chennai, Tamil Nadu, India.
  • VAISHNAVI S Department of Pharmaceutics, Sri Ramachandra Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research (DU), Chennai, Tamil Nadu, India.
  • PAVITHRA G M Department of Pharmaceutics, Sri Ramachandra Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research (DU), Chennai, Tamil Nadu, India.

Abstract

The cosmetics market is changing around the globe dramatically. The cosmetics safety, efficacy, regulatory framework, and marketing of cosmetic products are the important factors of the growth of the cosmetic industry. Cosmetic safety is regulated by diverse regulatory bodies of the globe, that is, the countries that have their own rules and regulations. The cosmetic market in India is Central Drug Standard Control Organization through the Drug and Cosmetic Act, 1940 and Rules 1945. India has stringent rules and regulations for cosmetic products. This manuscript describes the overall cosmetics scenario, requirements for registration of cosmetics import and manufacturing.

Keywords: Cosmetics, Current scenario, Labelling, Regulation, Registration Process

References

1. Wathoni N, Haerani A, Yuniarsih N, Haryanti R. A review on herbal cosmetics in Indonesia. Int J Appl Pharm 2018;10:13.
2. Arora R, Aggarwal G, Arora Dhingra G, Nagpal M. Herbal active ingredients used in skin cosmetics. Asian J Pharm Clin Res 2019;12:7-15.
3. Tiwari M, Dubey V, Lahiri A. Comparative study of various herbal cosmetics: A survey. Asian J Pharm Clin Res 2020;13:31-4.
4. Abdullah B, Hamdard J. A comparative study of cosmetic regulations in different countries of the world with focus on India. Int J Curr Res Rev 2012;4:130-43.
5. Tejal P, Nishad D, Amisha J, Umesh G, Desai K, Bansal R. Cosmetics and health: Usage, perceptions and awareness. Bangladesh J Med Sci 2013;12:392-7.
6. India Cosmetics Market Research Report; 2020. Available from: https:// www.goldsteinresearch.com/report/india-cosmetics-market-report-industry-analysis. [Last accessed on 2020 Oct 05].
7. Raj R, Chandrul K. Regulatory requirements for cosmetics in relation with regulatory authorities in India against US, Europe, Australia and Asean countries. Int J Pharm Res Health Sci 2016;4:1332-41.
8. Frequently Asked Questions on Registration and Import of Cosmetics in India; 2020. Available from: https://www.cdsco.gov.in/opencms/ export/sites/cdsco_web/pdf-documents/cosmetics/FAQs-cosmetics_ new.pdf. [Last accessed on 2021 Jan 08].
9. Singh B, Jain A, Mishra A. Cosmetic regulations in India vs. globally and challenges in harmonization. Int J Pharm Sci Drug Res 2018;10:150-7.
10. Cosmetic Regulation EC 1223/2009. Available from: https://www. ec.europa.eu/health/sites/health/files/endocrine_disruptors/docs/ cosmetic_1223_2009_regulation_en.pdf. [Last accessed on 2021 Jan 20].
11. Siri Sindhura DK, Jain V. Challenges in formulating herbal cosmetics. Int J Appl Pharm 2018;10:47.
12. Spencer N. India Set to Reduce Restrictions on Cosmetic Imports; 2016. Available from: https://www.cosmeticsdesign-asia.com/ article/2016/09/20/India-set-to-reduce-restrictions-on-cosmetic-imports. [Last accessed on 2020 Oct 05].
13. Bindra N. Home - NKG Advisory Business and Consulting Services Private Limited; 2020. Available from: https://www.nkgabc.com. [Last accessed on 2021 Jan 20].
14. Cosmetic Regulation in India, CliniExperts; 2016. Available from: https://www.cliniexperts.com/cosmetic-regulatory-affairs. [Last accessed on 2020 Oct 05].
15. Regulations for Cosmetics. Available from: https://www.cseindia.org/ regulations-for-cosmetics-5289. [Last accessed on 2020 Oct 05].
16. Available from: https://www.cdsco.gov.in/opencms/export/sites/cdsco_ web/pdf-documents/cosmetics/cosorgan.pdf. [Last accessed on 2020 Oct 05].
17. Anuradha S, Ganasan V, Joobi L, Arunkumar K. Cosmeceuticals”: An opinion in the direction of pharmaceuticals. Asian J Pharm Clin Res 2015;8:64-9.
18. Sharma P. Cosmeceuticals: Regulatory scenario in US, Erope and India. Int J Pharm Technol 2011;3:1512-35.
19. Nanjwade B, Bellad K, Kamble M, Srichana T, Idris N. Development of cosmeceuticals. World J Pharm Pharm Sci 2017;6:643-91.
20. Available from: http://www.shodhganga.inflibnet.ac.in/ bitstream/10603/4984/14/15_chapter%206.pdf. [Last accessed on 2020 Oct 05].
21. Guidelines on Registration of Import of Cosmetics; 2013. Available from: https://www.cdsco.gov.in/opencms/export/sites/CDSCO_WEB/ Pdf-documents/cosmetics/guidelines_on_registration_of_import_of_ cosmetics.pdf. [Last accessed on 2020 Oct 05].
22. Rathi H, Rathi P, Biyani M. Cosmetovigilance: A system ensuring safe use of cosmetics. Int J Med Sci Educ 2019;6:67-71.
23. Ramanuj A. Cosmetics Regulation in India – The Law you need to Know before Getting into Cosmetics Manufacturing Business; 2014. Available from: https://www.blog.ipleaders.in. [Last accessed on 2020 Oct 05].
24. Nagabhushanam P. Drugs and Cosmetics Act, 1940 and Rules, 1945. Tirupati, Andhra Pradesh: Drugs Control Administration; 2020.
25. Requirement of Factory Premises for Manufacture of Cosmetics. Schedule M-II; 2018. Available from: https://www.pharmastate.blog/ schedule-m-ii-requirement-of-factory-premises-for-manufacture-of-cosmetics/#:~:text=%EF%83%BC%20It%20shall%20be%20 suited,be%20brought%20in%20the%20premises. [Last accessed on 2021 Jan 08].
26. Ministry of Health and Family Welfare. Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products. New Delhi: Ministry of Health and Family Welfare; 2001.
27. Drugs Control Administration. Drugs and Cosmetics Act, 1940 and Rules, 1945. Tirupati, Andhra Pradesh: Drugs Control Administration; 2014.
28. Sankholkar DS. Current Indian regulations and suggested way forward. Pharm Times 2009;41:31-2.
29. Drugs Control Administration. The Drugs and Cosmetics Act and Rules: The Manufacture of Cosmetics for Sale or Distribution, Part 14, Rules 138. Tirupati, Andhra Pradesh: Drugs Control Administration; 2018.
30. Get Cosmetics Registration in India - Permission and License. Enterslice Fintech Private Limited. Available from: https://www.enterslice.com/ cosmetic-registration-india. [Last accessed on 2020 Oct 05].
31. Tamil Nadu Food Safety and Drugs Administration Department. Available from: http://www.drugscontrol.tn.gov.in/guidelines_ renewal_loan_licence_cosmetics_form_32_a.html. [Last accessed on 2021 Jan 20].
32. What is Form 42 and 43 for the Import of Cosmetics in India? Medium. Available from: https://www.medium.com/@rajni. digivigyan/what-is-form-42-and-43-for-the-import-of-cosmetics-in-india-8103c6c498e1#:~:text=Form%2043%20is%20the%20 registration,Drugs%20%26%20Cosmetics%20Act%2C%20 1945.&text=While%20form%2042%20is%20submitted,this%20 registration%20to%20the%20applicant. [Last accessed on 2021 Jan 20].
33. Compulsory Cosmetics Registration; 2012. Available from: http:// www.custada.in/custada-online/document/document/compulsory%20 cosmetics%20registration.html. [Last accessed on 2021 Jan 20].
34. Phookan M. India: Registration of Imported Cosmetics; 2011. Available from: https://www.iaccindia.com/userfiles/files/registration%20of%20 imported%20cosmetics%20in%20India.pdf. [Last accessed on 2020 Oct 05].
35. Welankiwar A. Review: Regulatory Provisions Regarding Cosmetics in India. Maharashtra: PharmaTutor; 2013.
36. Registration Procedure for Imports of Cosmetics in India. Available from: https://www.applyiec.in/registration-imports-cosmetics-india. [Last accessed on 2021 Jan 08].
37. Cosmetic License, Online Cosmetic Application for License, Legal Raasta. Available from: https://www.legalraasta.com/cosmetic-license/#:~:text=Importer%20requires%20to%20apply%20for,A%20 Subsidiary%20of%20the%20manufacturer. [Last accessed on 2021 Jan 08].
38. Bajpai S. Import License of Drugs and Cosmetics in India - Corpbiz; 2020. Available from: https://www.corpbiz.io/learning/import-license-of-drugs-and-cosmetics-in-india. [Last accessed on 2021 Jan 08].
39. India Cosmetic Regulation, ChemLinked; 2020. Available from: https://www.cosmetic.chemlinked.com/cosmepedia/india-cosmetic-regulation. [Last ccessed on 2021 Jan 08].
40. Cosmetic Registration Cost and Process India: BIATConsultant. Available from: https://www.biatconsultant.com/cosmetic-registration-india. [Last accessed on 2021 Jan 20].
41. Central Drugs Standard Control Organisation. Guidance Document on Common Submission Format for Import Registration of Cosmetics in India. New Delhi: Central Drugs Standard Control Organisation; 2007.
42. Cosmetic Registration India, Cosmetic License India, Cosmetic Import, CliniExperts. Available from: https://www.cliniexperts.com/india-regulatory-services/cosmetic. [Last accessed on 2020 Oct 05].
43. Cosmetic License and Registration in India - MyOnlineCA. Available from: https://www.myonlineca.in/cosmetic-license-and-registration-in-india. [Last accessed on 2021 Jan 20].
44. Chemical Watch; 2018. Available from: https://www.chemicalwatch. com/72614/india-publishes-extensive-draft-cosmetics-rules. [Last accessed on 2020 Oct 05].
45. Drug Registration Notification GSR 604 (E) Dated 24th August 2001; 2001. Available from: https://www.fdocuments.in/document/drug-registration-notification-gsr-604-e-dated-24th-august-2001.html. [Last accessed on 2021 Jan 20].
46. Cosmetics Registration in India - An Overview, Morulaa. Available from: https://www.morulaa.com/cdsco/cosmetics-registration-in-india. [Last accessed on 2020 Oct 05].
47. CDSCO Registration For Cosmetics Import. Available from: https:// www.wedoimport.com/compliance/cdsco-registration-for-cosmetics-import. [Last accessed on 2021 Jan 20].
48. Cosmetic License. Available from: https://www.mindsync.co.in/ cosmetic-license. [Last accessed on 2021 Jan 08].
49. FAQs - Cosmetics Import Registrations; 2017. Available from: https:// www.mnmedicaldeviceregulatory.com/faq-cosmetics.html. [Last accessed on 2021 Jan 20].
50. Cosmetics; 2020. Available from: https://www.cdsco.gov.in/opencms/ opencms/en/Cosmetics/cosmetics. [Last accessed on 2020 Oct 05].
51. BruderCosmogen. Available from: http://www.cosmetics-registration-in-india.com. [Last accessed 2020 Oct 05].
52. Permission and License Required to Make Cosmetics In India. FSSAI License Online; 2017. Available from: https://www.getfoodlicense. in/permission-license-required-make-cosmetics-india. [Last accessed 2020 Oct 05].
53. Available from: http://www.cdsco.gov.in/opencms/export/sites/ cdsco_web/pdfdocuments/cosmetics/clarification_for_import_and_ registration_ofcosmetics.pdf. [Last accessed on 2021 Jan 08].
54. Latest Developments in the area of Packaging and Labelling Laws in India-Corporate Law Newsletter. S.S Rana and Company; 2013. Available from: https://www.ssrana.in/articles/packaging-labelling-laws-india-corporate-law-newsletter. [Last accessed on 2021 Jan 20].
55. Bhardwaj P. Packaging and labelling of cosmetics. Int J Legal Dev Allied Issues 2017;3:135-53.
56. Central Drugs Standard Control Organisation. The Drugs and Cosmetics Rules, 1945. New Delhi: Central Drugs Standard Control Organisation; 1945.
57. Packing and Labeling Compliance for Cosmetics Products in India, S J EXIM-Q Freight; 2019. Available from: https://www.sjexim. services/2019/08/18/packing-and-labeling-compliance-for-cosmetics-products-in-india. [Last accessed on 2021 Jan 20].
58. Regulatory Provisions Relating to Advertisements and Personal Care Products in India. Available from: http://www.shodhganga.inflibnet. ac.in/jspui/bitstream/10603/145038/14/14_chapter%205.pdf. [Last accessed on 2020 Oct 05].
59. Central Drugs Standard Control Organisation. The Drugs and Cosmetics Act and Rules: Labeling, Packaging and Standards of Cosmetics, Part 15, Rules 148. New Delhi: Central Drugs Standard Control Organisation; 2016.
60. Ruhela M, Nagar L, Gupta A, Popli H. Cosmetics: Regulatory and market scenario for us and India. Pharm Innov J 2018;7:164-9.
61. Ravi P, Reddy DS, Ramu B, Rajkamal B. Comparative study on cosmetics legislation in India US and EU. World J Pharm Pharm Sci 2016;5:1.
62. Srikanth T, Hussen S, Abha A, Vasantharaju S, Gummudavelly S. A comparative view on cosmetic regulations: USA, EU and India. Sch Res Libr 2011;3:334-41.
63. India Overhauls Cosmetics Regulations - AZB and Partners; 2020. Available from: https://www.azbpartners.com/bank/india-overhauls-cosmetics-regulations. [Last accessed on 2021 Jan 20].
64. Sautebin L. A cosmetovigilance survey in Europe. Pharmacol Res 2007;55:455-60.
65. Sarma P, Kumar H, Medhi B. Cosmetovigilance in India: Need of the day. Indian J Pharmacol 2017;49:341-3.
Statistics
39 Views | 87 Downloads
Citations
How to Cite
S, N., V. S, and P. G M. “REGULATORY PROTOTYPE FOR COSMETICS IN INDIA”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 14, no. 5, May 2021, pp. 12-16, doi:10.22159/ajpcr.2021.v14i5.40461.
Section
Review Article(s)