CDSCO Launches Online Portal for Submission of Applications of PSURs MA of New Drugs, SNDs, FDCs, Biologicals & Veterinary
The submission of these online applications has now been made functional on the SUGAM portal. All applicants submitting PSURs shall utilise the checklist available on the portal to submit their online applications.
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CDSCO has decided to invite suggestions/ comments/ objections from stakeholders on its draft guidance document.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.
MoHFW Proposes to Permit Import of Drugs Through Cochin and Thiruvananthapuram Airports
The draft rules are now available for public scrutiny and will be open for consideration till March 28, 2024. Interested stakeholders, including industry professionals, organizations, and the general public, are encouraged to submit their objections and suggestions within the specified timeframe.
NPPA Fixes Ceiling Price of Several Formulations under Drugs (Prices Control) Order, 2013
The manufacturer shall issue a price list in Form–V from date of Notification to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. Every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.
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.
New Drug Manufacturing Rules Introduced to Strengthen Quality Standards
The Amendment Rules introduce a new set of guidelines titled “GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS” in Schedule M. The guidelines outline several key principles to be adhered to by pharmaceutical manufacturers, focusing on pharmaceutical quality systems, quality risk management, sanitation and hygiene, qualification and validation, complaints and adverse reactions, product recalls, and change control.
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.
