India’s New Cosmetics Rules, 2020
– Key Takeaways
There is no stopping to the booming growth of Indian Cosmetics market even during the Covid-19 era. In fact, an increased awareness about personal hygiene and inculcating strict skincare and haircare regime in daily life is only going to boost the beauty industry further. There is a rising preference for specialized cosmetics such as organically sourced products, make-up preparations, coloured cosmetics and beauty products suitable for various skin types and conditions. This accelerated surge in demand is creating a profitable chance for manufacturers – both local and international, and importers to supply an extensive range of beauty and personal healthcare products and introduce novel cosmetic items in India. To regulate cosmetic products sold to Indian consumers and ensure stringent health and safety measures in a post pandemic world, an elaborate set of revised guidelines dictated by the Central Drugs Standard Control Organization (CDSCO) has been enforced.
‘New Rules’ for the Indian Cosmetic Industry
Effective 15th December 2020, CDSCO laid out a fresh set of protocol for importation, manufacture, labelling, packing, sale, and distribution of cosmetics (as defined by the Drugs & Cosmetics Act 1940) in India under Cosmetics Rules 2020. To ensure a smooth transition, all licenses granted under the former Drugs and Cosmetics Rules 1945 will be deemed valid till their expiry or for a period of 18 months from the date of commencement of the new regulations, whichever comes later.
Any cosmetic product manufactured outside India can be made available in Indian market if the product formulation, label text and the claims on the label and website are compliant with the Cosmetic rules, 2020. Also, all cosmetics products entering India must be registered through the e- Governance portal (SUGAM) by applying in Form COS-1. Submission must be done by either the manufacturer or the authorized agent in India. Upon thorough review of the application form, CDSCO provides the registration certificate via Form COS-2. Few other highlights of the new regulations are mentioned below:
Import and Registration of Cosmetics in India
- The import registration certificate shall now remain valid for five (5) years from the date of issue.
- The statutory fees for imported cosmetics have been significantly reduced.
- Import of cosmetics are prohibited if (a) the “Use Before date” is less than six (6) months from the date of import, (b) the cosmetic contains hexachlorophene, a chemical preservative known for harmful effect on humans, (c) the cosmetic has been tested on animals after November 12, 2014.
- No cosmetic product whose manufacture, sale or distribution is prohibited in the country of origin, can be imported.
Cosmetics Manufacture for Sale or Distribution in India
- The manufacturing license/ loan license shall now remain valid for five (5) years from the date of issue.
- Mandatory self-declaration by applicant to confirm product compliance with good manufacturing practices and other guidelines.
- In case of manufacturing units at more than one premise, separate licenses to be obtained for each unit.
Quality and Ingredients
- To enable consumers to make more informed choices, it is now mandatory for manufacturers to declare all ingredients of their products, including those with concentration of less than 1%.
- Raw materials specified in Annex A of the Indian Standard IS: 4707 Part 2, as amended from time to time, shall not be added in the cosmetic product.
- No cosmetic shall be imported or manufactured which contains dyes, colours and pigments other than the one specified by the Bureau of Indian Standards
Voluntary Recall of Cosmetic Products
- If a manufacturer or authorized agent has reason to believe that a certain cosmetic product which has been imported, manufactured, sold, or distributed is likely a health-risk, it is obligatory for him to initiate procedures to recall the product from the market with immediate effect and inform Central Licensing Authority citing reasons for withdrawal.
What is ‘New Cosmetics’?
The Cosmetic Rules, 2020 has defined the term ‘New Cosmetics’ for the first time as a “cosmetic which contains novel ingredient and has not been used anywhere in the world or is not recognised for use in cosmetics in any National and International literature”. To import or manufacture New Cosmetics in India, one must seek prior permission from the Central Licensing Authority (CLA). An application in Form COS-12 must be accompanied with requisite data on safety and efficacy and must comply with IS 4011:2018 standards for testing. Due permission will be granted in Form COS-3 by the aforementioned authority.
In the complex regulatory landscape of the Indian Cosmetics industry, the New Rules have efficiently streamlined the regulatory requirements and standards entailing import, manufacture, sales, and distribution of cosmetics in India. To make the application process less cumbersome and time-consuming, a regulatory expert who is well versed with the new cosmetic guidelines plays a crucial role in supporting the manufacturers and importers to supply CDSCO compliant cosmetics to the Indian market. This not only ensures safety, quality, and efficacy of the products reaching consumers but also reduces the number of adverse events reporting, and recalls, in turn saving one’s valuable time and money.
The author of this blog Dr. Sravya is one of our in-house cosmetic regulatory experts. With hands-on experience in consulting for cosmetic manufacturing companies worldwide, her sharp eye for detail speaks for itself. You can find her on Linkedin.