Draft CDSCO Guidance Document on Post Approval Changes in Biological Products
CDSCO has decided to invite suggestions/ comments/ objections from stakeholders on its draft guidance document. These may be submitted by April 13, 2024.
CDSCO Directs Cosmetics Importers to Comply with Cosmetics Rules, 2020
All applicants importing cosmetics under COS-4A are now directed to furnish an annual statement to the Central Licensing Authority. This statement should comprehensively outline details such as the number of consignments and bill of entries for each consignment, the imported quantity in each consignment, total cost of imported cosmetics per consignment, warehouse details where the products are stored for further distribution and sale, among others.
CDSCO publishes List of NSQ Pharmaceuticals for December 2023
A total of 1008 samples were tested by the CDSCO. Based on the samples tested, CDSCO has found a total of 78 drugs, medical devices, vaccines and cosmetics that are identified as being not of standard quality.
India Strengthens International Cooperation in Medical Product Regulation
The Union Cabinet has been apprised of Memorandums of Intent (MoIs) and Understanding (MoUs) signed between the Central Drugs Standard Control Organization (CDSCO) and regulatory bodies from the Netherlands, the Dominican Republic and the Republic of Ecuador. These agreements focus on cooperation in the field of Medical Products Regulation.
CDSCO Launches Additional Forms on National Single Window System (NSWS Portal)
CDSCO has made the applications for grant of permission/ licence in Forms CT-10, CT-12, CT-13 live on the NSWS Portal from January 16, 2024. Form 12 will be live from January 24, 2024. All concerned stakeholders shall submit the above applications only through the NSWS Portal. The existing SUGAM online portal for these activities will be disabled from February 10, 2024.
CDSCO Notifies New Pathway For Clearance or Grant of Product Licence for Specified FDCs
The Central Drug Standard Control Organisation (CDSCO) has notified a new pathway for clearance or grant of product licence for specified FDCs. Moreover, all manufacturers must comply with the specified recommendations of the expert committee for revision of the prescribing information/ label.
Union Health Minister Inaugurates CDSCO Sub Zonal office & CDTL in Indore
The Central Drug Testing Laboratory, equipped with high-quality laboratory services, will play a crucial role in testing drugs, ensuring the availability of essential and high-quality medicines to improve the health of citizens. The facility is equipped with advanced instruments, including 12 HPLCs, 1 GLC, and 1 UV Spectrophotometer.
CDSCO Launches National Single Window System Portal
This portal has been designed to build a system that functions as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business. The NSWS Portal for CDSCO will be independent of the SUGAM Portal or the cdscomdonline portal.
CDSCO Streamlines Procedure for Evaluation of Applications
All copies of presentations before the SEC must be submitted through the e-vartalap (Sugam Portal). This submission must be made well in advance, upon receipt of the invitation letter from CDSCO. The submission must be made only to the concerned division.
New Label Warning for FDC of Chlorpheniramine Maleate IP 2mg And Phenylephrine HCI IP 5mg drop/ml
CDSCO has emphasised that all manufacturers of FDC of of Chlorpheniramine Maleate IP 2mg And Phenylephrine HCI IP 5mg drop/ml should mention a warning that ‘FDC should not be used in children below 4 years of age’. This should be included in the label and the package insert/ promotional literature of the drug.
