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.
CDSCO Publishes List Of Drugs Declared As Not Of Standard Quality And Spurious For May 2024
The NSQ drug list specifies a total of 13 drugs that were detected to be deficient by State Lab Drugs Control Laboratory, Telangana. Out of these 23 drugs, 8 were declared to be not of standard quality and the remaining 5 were misbranded. The NSQ drug list for central CDSCO laboratories specifies a total of 39 drugs that were detected to be deficient.
MoHFW Permits Import of Drugs Through Cochin and Thiruvananthapuram Airports
The Ministry of Health and Family Welfare (MoHFW) has sanctioned Cochin and Thiruvananthapuram airports for the import of drugs into the country. Prior to this amendment, drugs could be imported only through airports located at Chennai, Kolkata, Mumbai, Delhi, Ahmedabad, Hyderabad, Goa, Bengaluru and Visakhapatnam.
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cancer in patients with a gBRCA mutation and who have received three or more prior chemotherapy treatments is being withdrawn.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.
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.
