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CDSCO Sugam Portal Benefits and Limitations

CDSCO Sugam Portal Benefits and Limitations

CDSCO's Online Portals for Streamlined Regulatory Processes:

CDSCO's Streamlined Licensing Process

Overview of CDSCO Online Portals

In order to streamline the regulatory applications, submission, processing and grant of licenses in a transparent, fast and reliable fashion, the Central Drugs Standard Control Organization (CDSCO) launched various online portals, each catering to a specific type of service. These are,

  1. SUGAM Portal – Online portal for registration of drugs, formulations, ethics committee, BA/BE and Cosmetics to ensure transparency and ease for manufacturers to communicate with the CDSCO.
  2. SUGAM Online System for Medical Devices – A portal mainly used for import / manufacturing / retention / post approval changes and PMS data submission for medical devices and In vitro diagnostics (IVDs) to the CDSCO.
  3. State Drug Licensing System – State specific FDA for drug manufacturing and sales
  4. National Single Window System (NSWS) -A system for grant of registration certificate to notified body in Form MD-01, test license for manufacturing in Form MD-12 and test license for import in Form MD-16

Benefits in SUGAM and Other Online Portals:

SUGAM Challenges:

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Request your free proposal. Call us today, or fill out the form and we will get right back to you!