CDSCO issues revised guidance document for application of Export NOC for unapproved/approved new drugs to be obtained through Sugam Portal by Lexplosion | May 9, 2025 | Central, OPS, PharmaceuticalsThe Central Drugs Standard Control Organisation (‘CDSCO’), has issued a revised Guidance Document... Read More
CDSCO prohibits manufacture, sale and distribution of unapproved Fixed Dose Combinations (FDC) Drugs by Lexplosion | May 2, 2025 | Central, OPS, PharmaceuticalsThe Central Drugs Standard Control Organisation (“CDSCO”) has issued a Circular highlighting... Read More
CDSCO specifies time limit for processing of applications under Forms CT-07, CT-11, CT-14, CT-15, CT-17 under New Drugs and Clinical Trial Rules, 2019 by comtideging1971 | Feb 27, 2020 | OPS, Pharmaceuticals, statesThe Central Drugs Standard Control Organisation (“CDSCO”) has issued the following Notifications... Read More
CDSCO clarifies concerns raised regarding BA/BE, FDCs, INDs, license/permission for import/manufacture of new drugs or clinical trial, sub acute toxicity report study and stability data for COPP by comtideging1971 | Feb 27, 2020 | OPS, Pharmaceuticals, statesThe Central Drugs Standard Control Organization (“CDSCO”), has issued 6 noticed dated... Read More
All healthcare professionals and clinicians must inform Authorities about the Materiovigilance Programme of India to ensure proper monitoring of medical devices; says CDSCO by comtideging1971 | Dec 6, 2019 | Healthcare, OPS, statesIn a Notification dated 26th November 2019 the Central Drugs Standard Control Organisation... Read More