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,
- 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.
- 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.
- State Drug Licensing System – State specific FDA for drug manufacturing and sales
- 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:
- The registration, document review, submission and tracking has become much simpler, efficient and transparent with the CDSCO via the SUGAM Portal system.
- Helps in keeping track of all past regulatory applications with the CDSCO, current applications and future saved applications for submission under one portal.
- Separate icon bars are available for saved, submitted, Approved, rejected registrations for viewing.
- After submitting the application to CDSCO online SUGAM Portal, status bar will show how many days left to get answer from CDSCO
- CDSCO have introduced a New Notification Announcement section which displays any new notifications in the last 7 days. This helps in keeping track of any updates/changes in the rules from the CDSCO
- It has been made easier to apply for change notifications once the Regulatory Certificate or License is obtained. This can be done in the section “Post Approval Change” section in the SUGAM Portal.
- Downloading the checklist prior to review from the SUGAM Portal is beneficial enabling us to start reviewing the files in the required format making uploading easy.
- If a query is raised by the CDSCO after the submission of the application, a message via SMS alert is sent.
- Ease of uploading the Periodic Safety Update Reports (PSUR) with respect to market authorization of the medical device or IVD
SUGAM Challenges:
- There is no provision to upload files greater than 10MB file size
- There is no provision to upload multiple different files for one heading. Companies can only combine them as one PDF giving the possibility of information getting misplaced.
- It is mandatory to upload ALL files even if the document is not applicable. Hence a 1 page doc PDF must be uploaded saying “Not applicable” on the manufacturer’s or Indian agent’s letter head.