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cancer in patients with a gBRCA mutation and who have received three or more prior chemotherapy treatments is being withdrawn.
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.
