FASTER PRODUCT APPROVALS LEADING TO ENHANCED ACCESS TO MARKETS !
In India, the latest Cosmetics Import & Marketing regulatory mandate, enforced from 1st April 2013, requires registration of the manufacturing site/s and the product/s with the Indian licensing authority – the CDSCO. This activity is an essential requirement to ensure that Cosmetics Manufacturers based outside of India, can Import and Market their products in India.
In brief, the cosmetics manufacturer needs to apply for the products’ registration through their registered office in India, or their Subsidiary or through an Importer or a India based Authorised Agent. The actual application for product registration is submitted to the CDSCO, using “Form 42”, the required essential documents and in the specified submission format. On successful review of the submitted dossier, the CDSCO will issue a “licence” in the form of a “Registration Certificate (RC)”.
This issued Registration Certificate, is both manufacturing site and product list specific. The manufacturer, through his subsidiary or importer or a India based Authorised agent can import the list of products specified in the RC only from the manufacturing so specified in the RC. In other words this RC is the equivalent of an Import License or Market Authorisation.
Optimus provides both Market / Product Authorisation 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.
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.,