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.
CDSCO Imposes Limit on Cosmetic Product Applications
Effective from August 16, 2024, applicants can now submit a maximum of fifty products per application. By limiting the number of products per application, the CDSCO aims to streamline the application process and expedite the review and approval timelines.
Government Seeks Public Feedback on Drug Distribution Practices
The Central Drugs Standard Organisation (CDSCO) is seeking public feedback on draft guidelines for Good Distribution Practices (GDP) for pharmaceutical products. These guidelines aim to ensure proper storage and handling of medicines throughout the supply chain, from manufacturers to retailers.
India Exempts Local Clinical Trials For New Foreign Drugs
The Indian government has announced a streamlined approval process for certain categories of new drugs recognizing approvals from key global regulatory authorities. CDSCO has specified a waiver from local clinical trials for USA, UK, Japan, Australia, Canada, and the European Union (EU).
Relaxing Norms for Toxicity Studies in Drug Approval
The CDSCO aims to streamline the drug approval process without compromising safety. The New Drugs and Clinical Trials Rules, 2019 allow for the acceptance of preclinical toxicity data generated in other countries, provided the data is of high quality and meets specified standards.
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.
