CDSCO Publishes List Of Drugs Declared As Not Of Standard Quality And Spurious For June 2024
The NSQ drug list specifies a total of 30 drugs that were detected to be deficient by State Lab Drugs Control Laboratory, Telangana. All of these 30 drugs were declared to be not of standard quality and 2 were also found to be misbranded. The NSQ drug list for central CDSCO laboratories specifies a total of 31 drugs that were detected to be deficient.
Government Proposes New Labeling Requirements for Drugs
These draft rules propose the inclusion of “details of excipients” on all drug labels. The amendment also proposes replacing semicolons with full stops (periods) after “date of expiry” and “manufacturing license number” to improve clarity and separation of information.
Updates On Use of Olaparib Tablets for Ovarian Cancer Treatment
The initially approved use of Olaparib for advanced ovarian cancer in patients with a gBRCA mutation and who have received three or more prior chemotherapy treatments is being withdrawn.
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.
