Grace Period Granted for Class C & D Medical Device Licensing
CDSCO has decided that existing importers and manufacturers of Class C & D medical devices who submitted license applications to the Central Licensing Authority (CLA) by September 30, 2023, can continue their operations till August 16, 2024.
Medical Device License Holders Urged to Report Adverse Events On MvPI Platform
All medical device license holders are urged to strengthen their post-market surveillance systems and report adverse events promptly through appropriate channels, including the MvPI platform. License holders must have robust systems for identifying, documenting, and reporting adverse events associated with their devices.
CDSCO Issues Reminder For Payment Of Medical Device License Renewal Fees
The circular states that licenses for manufacturing or importing medical devices, and registration certificates for quality management system (QMS) audits and medical device testing labs, are issued indefinitely however, all stakeholders should ensure timely payment of the necessary fees to the designated government account before the deadline to maintain product market continuity.
New NOC From CDSCO Zonal Offices Required for Export of Unapproved Or Banned Drugs
The Central Drugs Standard Control Organization (CDSCO) has announced a simplified process for obtaining No Objection Certificates (NOCs) for exporting unapproved, banned, or new drugs. Manufacturers shall obtain NOCs from CDSCO zonal offices through the online SUGAM portal (effective May 15th, 2024) before applying for a manufacturing license from state authorities.
DGHS Cracksdown On Unapproved Drug Manufacturing
All manufacturers are directed to cease the production of Meropenem and Disodium EDTA for injection immediately. Additionally, the product permissions granted for these drugs will be canceled without delay.
DCGI Cancels Upcoming Meetings with Stakeholders
The Central Drug Standard Control Organisation (CDSCO) has issued a public notice notifying the cancellation of stakeholder meetings with the Drug Controller General of India (DCGI). The CDSCO has stated that due to exigency of work and other official commitments, the meetings dated 7th, 12th and 14th March, 2024 stand cancelled.
CDSCO Launches Online Portal for Submission of Applications of PSURs MA of New Drugs, SNDs, FDCs, Biologicals & Veterinary
The submission of these online applications has now been made functional on the SUGAM portal. All applicants submitting PSURs shall utilise the checklist available on the portal to submit their online applications.
Draft CDSCO Guidance Document on Post Approval Changes in Biological Products
CDSCO has decided to invite suggestions/ comments/ objections from stakeholders on its draft guidance document. These may be submitted by April 13, 2024.
CDSCO Directs Cosmetics Importers to Comply with Cosmetics Rules, 2020
All applicants importing cosmetics under COS-4A are now directed to furnish an annual statement to the Central Licensing Authority. This statement should comprehensively outline details such as the number of consignments and bill of entries for each consignment, the imported quantity in each consignment, total cost of imported cosmetics per consignment, warehouse details where the products are stored for further distribution and sale, among others.
CDSCO publishes List of NSQ Pharmaceuticals for December 2023
A total of 1008 samples were tested by the CDSCO. Based on the samples tested, CDSCO has found a total of 78 drugs, medical devices, vaccines and cosmetics that are identified as being not of standard quality.
