Faster Product Approvals Leading to Enhanced Access to Markets !
The following are some of the product categories regulated by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India : Pharmaceuticals, Biologics, Medical Devices, rDNA products, In-Vitro Diagnostics, Blood & blood products, Cosmetics, Veterinary, Ayurvedic, Homeopathic, Herbals, Biosimilars, Vaccines, Generics, Fixed Dose Combinations.
In general, any regulated product which is to be tested or sold in India, has to be registered with the licensing authority (CDSCO) through various procedures. Products tested or sold in India, could be manufactured locally or can be manufactured outside India but Imported for sale or testing into India. Any manufacturer who wishes to import and market products manufactured outside of India, should register the manufacturing site and the list of products which they propose to import for sale. This Product Registration process leading to Market Authorisation can be implemented only through the manufacturer’s registered office in India, or their Subsidiary or through an Importer or an India based Authorised Agent.
Vyomus Consulting provides both Product Registration Services and Authorized Agent Services to all categories of regulated products indicate above. An end-to-end service offering which will help you import and sell your product in India, efficiently so as to achieve faster product approvals leading to enhanced access to Markets and Opportunities.
In brief, the regulated product manufacturer needs to apply for products registration in India through their registered office in India, or their Subsidiary or through an Importer or an India based Authorized 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 “Registration Certificate (RC)”.
This issued Registration Certificate, is both manufacturing site and product list specific. Based on this issued Registration Certificate, the manufacturer, through his Authorized Agent can apply for and obtain an Importer(distributor) and Product specific Import License (Form 10). The Importer (normally the distributor) can then use this Import License (Form 10) to physically import and “clear” the consignment from port authorities and market, sell the products in India. Multiple Form 10’s can be obtained for a single Registration Certificate.
In summary, the Registration Certificate and Import License together constitute “Market Authorisation” for products which require to be imported, to be sold in India.
Vyomus Consulting 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 Patient Information / Instructions for Use leaflets
- Post marketing services including Complaint handling, Adverse incident Reporting & Management and product recall support as part of Product safety reporting, Query management, PSUR Writing & 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.,
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