WE WANT YOUR PROJECTS AND YOUR BUSINESS TO SUCCEED !
In order to legally register, import and market, sell your cosmetic products in India you need to be compliant to Indian regulations and legislation. The government of India has notified the requirement for registration of “Import (for sale) of Cosmetics” through its Gazette Notification G.S.R 426(E) dated 19th May 2010. This regulation was implemented from 1st April 2013. In simple terms, any cosmetic product/brand which is to be imported into India for sale, has to be registered with the Indian Drug & Cosmetics Regulatory Agency (licensing agency) – CDSCO.
In summary, cosmetics manufacturer/s who wish to import and market their products in India, have to register their manufacturing site/s and product/s through their registered office in India, or their Subsidiary or through an Importer or a India based Authorised Agent.
Optimus provides both Product Registration Services as well as Authorised Agent Services. An end-to-end service offering which will help you import and sell your product in India, so as to achieve faster product approvals leading to enhanced access to Markets and Opportunities.
Optimus will represent your organization as your official Indian Authorized Representative / Agent in accordance with India applicable regulatory legislation: The Drugs and Cosmetics Act and Rules.
Only one Indian Authorized Representative office is needed for the whole country. Optimus will represent you legally in India without any commercial conflict of interest activities like product distribution, product marketing, product sales etc.
Product registration services include the following :
- Regulatory Strategy Consulting and Liaison
- Complete Product Life Cycle Management
- Compilation of India specific submission dossiers
- Submission management leading to approvals
- India Specific Labelling and Instructions for Use leaflets
- Post marketing services including Complaint handling, Query management & Submission activities
- All statutory Marketing Authorization holder’s requirements
- Act as your India Regulatory Department by Applying and Maintaining required Authorizations, Prepare and review regulatory submission material for compliance to India legislation etc.,