Amendment in Cosmetic Registration Certificate
The Government of India has issued a gazette notification G.S.R. 426(E) dated 19th May 2010 making it mandatory to register all imported cosmetics. This amendment was notified in the gazette amending Rule 129 of Drugs & Cosmetics Rules. The amendment and the provisions as in the amendment came into force from 1st April, 2012.
Fresh Registration
After obtaining a Cosmetic Registration Certificate, The following changes require a fresh registration –
- Any change with respect to manufacturer (legal/ actual) like change in name, change in constitution, change in address, etc. Any change with respect to importer/ Indian Agent like change in name, change in constitution, etc.
- The manufacturer or his authorized agent in India should inform the licensing authority as soon as possible if any change in the constitution of the firm and/or address of the registered office/factory premises functioning under this Registration Certificate. In such cases, the current Registration Certificate shall be valid for a maximum period of three months from the date on which the change has taken place from the date on which the change has taken place unless, in the meantime, a new Registration Certificate has been given by the licensing authority in the name of the firm with the changed constitution of firm and/or changed address of registered office or factory premises (as per condition no.4 of Form COS-2).
- In case of acquisition/merger of one company by another company, the Indian agent / Importer has to inform the licensing authority immediately in writing and has to submit a fresh application as per Rules, as acquisition/merger of one company is considered as change in constitution of the company.
Changes that require fresh registration:
Following changes do not require a new/fresh registration and only notification or amendment may be obtained –
 Change in the method of testing
 Change in composition
 Updating in packaging and labels (provided proper justification should be provided for the above changes)
 Minor changes in the manufacturing process that will not affect the final product specifications
Amendments for products not tested on animals
A one-time self-declaration that the products applied for registration has not been tested on animals on and after 12.11.2014 along with import registration dossiers should be submitted to the CDSCO by the manufacturer either legal or actual/brand owner of the products/Indian subsidiaries. For clearing of consignments, the acknowledgement copy as received by the applicants from CDSCO shall be submitted at the port offices.
Re-registration of Cosmetic Products
In response to better lifestyle approach, high purchasing capacity and self care, the demand for cosmetic products in India has risen expeditiously. To protect and maintain the worth of cosmetics in India, the cosmetic products are regulated under the provisions of the Drugs & Cosmetic Act vide Gazette notification G.S.R 426(E). A registration certificate of a cosmetic product is valid for a period of three years from the date of its issue. It required to be renewed after the given validity. However, it can be suspended or cancelled, in case of violence of rules. The registration as well as re-registration of cosmetic products is required to ensure its quality, efficacy and safety, but, it brings along a tedious paper work that has to be accomplished to maintain the registration of a cosmetic product under a Brand. Cosmetics Consultants India Pty bestows an easy- hassle free approach to resolve technical as well as non technical challenges associated with the renewal of registration of Cosmetic products. We own the expertise and skills required to achieve goals in stringent timelines, that too in a smooth and tranquil way. Our regulatory specialists are striving all day to make the process of re-registration smooth to avoid unwanted frictions and anomalies, so as to accomplish the task well in time.
Documents required for re- registration of cosmetic products
A new set of clarifications has been issued by the Central Drugs Standard Control Organization (CDSCO) on 15th of October, 2015 along with the existing guidelines, focusing on the import and registration of cosmetics. In addition to this, a string of documents required to renew the registration certificate are also enlisted. The string of documents includes:
- Power of attorneyin original;
- Necessary fees;
- Duly filled and signed Form COS-1 along with the list of products to be renewed;
- Certificate of free sale or manufacturing license or marketing authorization letter if any;
- Copies of original endorsement certificates that were granted earlier; and
- Undertaking/ self-declaration stating that there are no changes in information that was shared earlier as regards product details (like composition, test methods, specifications, label (in compliance with Rule 148 of D&C Rules) etc., constitution of the firm and sourcing location / site of the products.
Cosmetics Consultants India Pty have a team of experienced regulatory professionals who cater the requirements of regulatory authorities, market authorization as well as simplify the process of getting the Re-registration Certificate
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.