Regulation Against Excessive And Irrational Use Of Antibiotics
State Licensing Authorities (SLAs) are required to submit a list of all licensed antibiotic combinations within two weeks. They shall also monitor their jurisdiction for the presence of unapproved antibiotic combinations and take action against violators. SLAs shall also report any unapproved combinations to the CDSCO on a priority basis.
CDSCO Publishes List Of Drugs Declared As Not Of Standard Quality And Spurious For April 2024
The spurious drug list specifies a total of 5 products/ drugs that were detected to be spurious in nature. The NSQ drug list specifies a total of 50 products/ drugs that were detected to be not of standard quality. Out of these 33 were reported from CDSCO/Central Laboratories and the remaining 17 were reported from state laboratories.
CDSCO Warns Staff Against Improper Use of Digital Signatures
Digital Signature Certificates enable secure electronic signatures for online processes like form submissions, No Objection Certificates (NOCs), and document transmission. CDSCO emphasizes that employees must use their DSCs personally in their official capacities.
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.
