Form COS-1 Fresh Application for Cosmetics Import Registration
A “Fresh application” for registration of imported cosmetics in Form COS-1 has to be made in case when the brand is being registered by an Importing Entity for the first time.
If the Legal Manufacturer is one common entity, then A single application may be made in Form COS-1 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 COS-2 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.
A detailed list of documents and step by step procedure to prepare a correct and complete regulatory dossier for registration of imported cosmetics is detailed here.
The internal targeted timeline of CDSCO for processing of such application is 90 days from submission of this application whereas the notified timeline in the ACT is 6 months from date of submission.
The government fee for registration of imported cosmetics is calculated based on the product category and product variant and a detailed Description Product Categorization and Government fees.
COS-1 Application Dossier Compilation Checklist of Services
Cosmetic regulations in India are new and evolving from time to time. Various factors such as advances in science and global manufacturing practises, new technologies, formulations, newer raw materials, further accurate testing, effect on wildlife as well as climate keep pushing for evolving regulatory norms around the world. When such changes happen globally as well as in India, it leads to changes in regulatory expectations. Something which was right till yesterday could be not so right today.
At the same time, you are looking to launch your brand in India.You are hiring PR agencies, personel, Marketing initiatives, retail spaces, trainers etc. Basically you are going all out to grab your rightful share in the Indian market. In the midst of all this entrepreneurial rush, Such evolving regulatory changes or expectations can disrupt business plans greatly.
This is where Cosmetics Consultants India Pty experts comes in the picture.
Cosmetics Consultants India Pty team brings method in this madness. We try to identify the variables and keep working with our clients and helping formulate the best regulatory strategy as changes keep happening.
Cosmetics Consultants India Pty team has designed regular and value added services for importers and overseas brands looking to place their products in the Indian Markets. These services have been designed in a way to cover the exhaustive spectrum of regulatory needs that may be required from time to time.
The Manufacturer himself having registered office in India
- Product List with Product names, Pack Sizes, Variants if any
- GMP Copy of Manufacturer
- Artworks of all products
- IEC Certificate Indian Importing company
Processing of Apostille Documents
- POA Attestation
- Free sale certificate Attestation
- GMP Attestation
Preparation of Secondary Documents
- Ingredient List with Quantitative Data
- Certificate of Analysis
- Non Animal Testing Declaration
- Heavy metal declaration
- Testing Methods
- Microbeads Declaration
- Declaration for Non Human Cells to tissues
Submit a Request to CDSCO for Opening of SUGAM Account to upload the Documents
Payment of Government fees
Government fees of USD 2000 for a category and USD 50 Per Variant must be Paid on SUGAM Account to Submit file
System Generated COS-1
Once the Fees is Paid a System Generated COS-1 is downloaded which must be signed and stamped by Indian Entity
Once COS-1 is Uploaded, File is submitted and a unique File no. is Provided to applicant
Processing by CDSCO
Once the file is submitted CDSCO Takes 6-8 weeks for Grant of Approval or Raise a Query for clarification
In case a Clarification is Raised, CDSCO WIll issue a Online Query and we have to submit the Reply on thePoints Query is raised
After a Query is raised CDSCO Shall Grant approval in another 3-4 weeks and issue a Certificate Named COS-2 which can be Used for Import of Cosmetics Products
Post Registration Notification of Change in Registered Cosmetic Product
There are times where post grant of valid registration certificate, the registered products undergo some change with respect to the formulation of the product, specification of the product or artworks. These are considered as cases of Minor changes but still require some regulatory actions in order to keep the products under compliance with the approved standards or specifications set in Drugs & Cosmetics Act and by Bureau of Indian Standards.
Such changes are required to be mandatorily “NOTIFIED” to CDSCO.
Cosmetics Consultants India Pty experts work closely with its clients in understanding the the nature of such changes that may happen from time to time and follow a simple and efficient process of submission of “Notifications of change in registered product post registration to CDSCO so that the products of the clients are always in compliance with the various rules and regulations.”
COSMETICS CONSULTANTS INDIA PTY – KNOWLEDGEABLE & RESOURCEFUL
Preparing regulatory documents is a time consuming and meticulous exercise. As an Importer or Brand Owner, you must be already engrossed in various business aspects prior to launch of a brand in India.
An incorrect understanding of how to apply for the Cosmetics Import Registration or if a mistake is made, it can lead to complete delay in business plan, overheads, financial planning issues as well as supply chain disruption.
We provide the foreign manufacturers or their Indian Agents our timely services of perfect Cosmetics Regulatory Compliances, Imports Registrations and Marketing Consultancy with unquestionable professional ethics and up-to-the-minute knowledge and resources.