Who can apply for registration of imported cosmetics?
Cosmetic Products in India are regulated by CDSCO, Ministry of Health India.
It is mandatory to obtain a registration certificate in FORM 43 issued by CDSCO from the office of DCGI before one imports any cosmetic products in India.
Before preparing an application for registration, it is important to note what are the ways in which an Overseas manufactured Brand or products can enter into India.
Who CAN apply for registration?
As per the “Guidelines to Registration of Imported Cosmetics” document issued by CDSCO, An application for Issuance of Registration certificate in Form 43 must be applied on SUGAM Portal of CDSCO in a Prescribed form 42 either by
The Manufacturer himself having registered office in India
A “Manufacturer” means a person or entity in a Country other than India who owns the trade name of the brand of the cosmetic product for which registration has been applied for and who/which manufactures such product at his/its own manufacturing site or at a site owned by another manufacturer in the trade name of his/its brand.
The Authorised agent of the Manufacturer
An “Authorized Agent” means a person or entity in India authorized by the manufacturer. The authorized agent will be responsible for the business activities of the manufacturer in India including compliance to the provisions of the Act in all respects.
The Subsidiary in India of the manufacturer
“Subsidiary”means an entity in India owned by the manufacturer
Any other importer in India
“Any other importer”means any person or entity purporting to import cosmetic products other than the manufacturer, its authorised agent and its subsidiary.
What is the difference between a legal manufacturer and actual manufacturer?
Legal Manufacturer
A person or entity in a Country other than India who owns the trade name of the brand of the Cosmetic product for which registration has been applied for and who/which manufactures such product at his/its own manufacturing site or at a site owned by another manufacturer in the trade name of his/its brand.
Actual Manufacturer
The actual manufacturing site of the products.
I am an Overseas Brand Owner, can I directly make an application to CDSCO?
An application for registration of cosmetics can ONLY be submitted in the name of an Indian entity. An overseas company cannot submit an application for registration without nominating an Indian Entity through a Power of Attorney (format and procedure prescribed as per Drugs & Cosmetics Act 1940). An Overseas brand holder who has manufacturing units overseas has to appoint an Indian Entity as License Holder/Importer who will ultimately submit the application.
Okay, so How can I make an application for registration of imported cosmetics?
If the Legal Manufacturer is one common entity, then A single application may be made in Form 42 for any number of brands manufactured at one or more locations by such legal manufacturer.
Finally, the office of DCGI, CDSCO will issue a single registration certificate in Form 43 in an application for registration of import of cosmetics for any number of brands/products manufactured at one or more locations by a single manufacturer.
In case of a legal manufacturer NOT having its own manufacturing site, but getting products manufactured at an overseas manufacturing site owned by someone else, then all such products can be clubbed in a single application.
However, if the legal manufacturer of the brand/product changes, in such a case, separate applications for registration of import of cosmetics have to be submitted to CDSCO for processing and eventual grant of approval in Form 43.
Each such application for registration of imported cosmetics has to be accompanied by a fee of USD 2000 or its equivalent Indian rupees for each Brand viz. each category of cosmetics as mentioned in Column 3 of the list enclosed at Annexure as well as USD 50 or its equivalent Indian rupees for each variant.
I want to import an overseas Brand but the products are being manufactured in multiple countries. Will this mean I have to submit multiple applications?
Since the Legal Manufacturer in such a case is one and that legal manufacturer is subcontracting the act of manufacture of products bearing its own trade name, then we can make a single application for registration of cosmetics meant for import into India.
At NKG, Our Knowledge is up-to-date and is based on the provisions of the LAW. We do not beat around the bush and tell our clients what they need to know.Founded in 2004 , NKG team has more than 70 years of cumulative regulatory experience amongst the core team members. We immediately act as Asset and let our clients focus on their CORE activities and leave the Regulatory Compliance and approvals to us.
An incorrect understanding of how to make an application for registration may lead to a lot of back and forth in the processing of application post submission that may lead to further frustration and loss of time.NKG experts use our deep understanding of how various business models work around the world and in India and help clients prepare the correct applications.
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