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.
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CDSCO has decided to invite suggestions/ comments/ objections from stakeholders on its draft guidance document.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.
