Faster Product Approvals Leading to Enhanced Access to Markets !
In India, the major source for regulation of all medicinal products, whether imported or locally produced in India, is the Drugs and Cosmetics Act, 1940 (DCA) under which are the Drugs and Cosmetics Rules. The DCA regulates the import, manufacture, distribution and sale of drugs in India and the legislation is enforced by the Union Government (Department of Chemicals and Fertilizers, Ministry of Chemicals and Petrochemicals) primarily through the office of the Drugs Controller General of India (DCGI) / Central Drugs Standard Control Organisation (CDSCO).
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.
Vyomus Consulting provides licensing services and where required, Authorized Agent Services to all categories of regulated products. An end-to-end service offering which will help you import, manufacture, stock, distribute and sell your product/s in India, efficiently so as to achieve faster product approvals leading to enhanced access to Markets and Opportunities.
In brief, the regulated product business owner (importer, manufacturer, stockist, distributor, wholesaler, retailer) needs to apply, and obtain or maintain, the required licenses(given below) from CDSCO or the state drug regulator as the case may be. Granting of the specific license and keeping it current, is essential to permit the business owner to initiate and continue their business, 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 Licensing holder’s requirements
- Act as your India Regulatory Department by Applying and Maintaining required Licenses, Prepare and review regulatory submission material for compliance to India legislation etc.,
The following are a snapshot of the licenses required to conduct pharmaceutical business in India :
|1.||Import and Marketing||Form 41, Form 45, Form 10.||Registration certificate, Permission to import finished formulation of a New Drug, Import License.|
|2.||Product Testing||Form 11, Form 29||License to import drugs for the purposes of examination, test or analysis, License to manufacture drugs for purposes of examination, test or analysis.|
|3.||Manufacturing||Form 25, Form 25B, Form 28, Form 46,||License to manufacture for sale, License to repack, Approval for manufacture a New Drug Formulation.|
|4.||Contract Manufacturing||Form 25A,||Loan license to manufacture for sale.|
|5.||Wholesale Distribution||Form 20B, Form 20G, Form 21B,||License to sell, stock or exhibit or offer for sale by wholesale.|
|6.||Retail Sale||Form 20, Form 20F, Form 21,||License to sell, stock or exhibit or offer for sale by retail.|
|7.||Clinical Trials||Form 45, Form 45A, Form 46, Form 46A||Permission to conduct Clinical Trials.|
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