CDSCO Publishes Not Of Standard Quality And Spurious Alert For October 2024
The NSQ drug list specifies a total of 34 drugs that were detected to be deficient by State Lab Drugs Control Laboratories. The NSQ drug list for central CDSCO laboratories specifies a total of 56 drugs that were detected to be deficient. Additionally, CDSCO has also identified 3 drugs to be spurious.
CDSCO Organizes Round Table to Discuss Cosmetics Regulations with Stakeholders
The Central Drugs Standard Control Organization (CDSCO) has invited manufacturers, importers, and industry associations to a roundtable meeting to discuss issues related to cosmetics regulations. The meeting is scheduled for November 19, 2024, at 4:00 PM at CDSCO headquarters in New Delhi. It aims to foster dialogue and collaboration between regulators and industry representatives.
New Recruitment Rules for Medical Device Regulatory Positions
The rules specify the number, classification, and pay level for various medical device regulatory positions. The method of recruitment, age limit, qualifications, and other eligibility criteria for each post are also outlined. Existing employees in relevant positions will be deemed to have been appointed under these new rules.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For September 2024
The NSQ drug list specifies a total of 18 drugs that were detected to be deficient by State Lab Drugs Control Laboratories. All of these 18 drugs were declared to be not of standard quality. The NSQ drug list for central CDSCO laboratories specifies a total of 49 drugs that were detected to be deficient. Additionally, CDSCO has also identified 4 drugs to be spurious.
New Version Of Medical Device Adverse Event Reporting Form Released
The Central Drugs Standard Control Organization (CDSCO) has released a new version of the Medical Device Adverse Event Reporting Form under the Materiovigilance Program of India (MvPI), i.e. version 1.2. This form was released on October 8, 2024.
CDSCO Requires Registration Of Clinical Research Organizations
The Central Drugs Standard Control Organization (CDSCO) has announced amendments to the New Drugs and Clinical Trials Rules, 2019. These amendments aim to strengthen the regulatory framework for clinical research organizations (CROs) in India. CROs are now required to register with the Central Licensing Authority before conducting clinical trials.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For August 2024
The NSQ drug list specifies a total of 11 drugs that were detected to be deficient by State Lab Drugs Control Laboratory, Telangana. All of these 11 drugs were declared to be not of standard quality. The NSQ drug list for central CDSCO laboratories specifies a total of 48 drugs that were detected to be deficient. Additionally, CDSCO has also identified 5 drugs to be spurious.
CDSCO Seeks Public Input on Revised Good Clinical Practices Guidelines
Good Clinical Practice is a set of guidelines for biomedical studies which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human participants. Stakeholders are encouraged to submit their comments and suggestions on the draft guidelines. Comments can be submitted electronically within by October 12, 2024 to dci@nic.in.
Voluntary Recall Of Tisseel LYO Fibrin Sealant Kits
Healthcare providers may continue to safely use the products if the fibrin sealant is prepared in advance to ensure it is fully dissolved and ready to be used when needed. If the Sealer Protein Concentrate has not fully dissolved, discard the vial, and prepare a fresh kit. If a customer has unused Tisseel Fibrin Sealant Kits that they would like to return, they are requested to contact Baxter Healthcare Center for Service to arrange for return and credit.
CDSCO Publishes Not Of Standard Quality Alert For July 2024
The NSQ drug list specifies a total of 13 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. The NSQ drug list for central CDSCO laboratories specifies a total of 57 drugs that were detected to be deficient.
