CDSCO allows operational continuity for importers and manufacturers of Class C & D Medical Devices; pending pre-September 2023 licensing applications deemed valid until 16th August, 2024 or CLA decision by Lexplosion | May 21, 2024 | Central, OPS, PharmaceuticalsThe Central Drugs Standard Control Organization (CDSCO) has issued a Circular in response to... Read More
NOC for manufacture of unapproved/approved new drugs/banned drugs (solely for export) to be obtained from Zonal offices via Sugam Portal, effective from 15th May 2024: CDSCO by Lexplosion | May 15, 2024 | Central, OPS, PharmaceuticalsThe Central Drugs Control Standards Organization (CDSCO) has communicated to drug controllers of... Read More
Public comments invited till 25th April, 2024 on draft of revised guidance for industry to align with the New Drugs and Clinical Trials (NDCT) Rules, 2019 and Sugam application process (Version 1.2) by Lexplosion Solution | Apr 19, 2024 | Central, OPS, PharmaceuticalsWith a view to align the submission procedure of clinical trial application (as prescribed under... Read More
Health Ministry sets 31st December, 2024 as implementation date for Jan Vishwas Act amendments to Drugs and Cosmetics Act, 1940; drug manufacturers may be subject to increased fines for utilizing government analysts’ reports in advertisements by Lexplosion Solution | Apr 4, 2024 | Central, OPS, PharmaceuticalsPursuant to the Update reported earlier on Jan Vishwas (Amendment of Provisions) Act 2023 (please... Read More
Health Ministry revises Drugs Rules 1945; permits tablet and capsule quantities exceeding 10 to be packaged in multiples of both 7 and 5 by Lexplosion Solution | Mar 21, 2024 | Central, OPS, PharmaceuticalsIn furtherance to what we reported earlier (please refer to e-mails in trail), the Ministry of... Read More
CDSCO mandates online submission of Period Safety Update Reports (PSURs) through Sugam Portal, offline submissions to be discontinued from 11th March, 2024 by Lexplosion Solution | Feb 29, 2024 | Central, OPS, PharmaceuticalsWith a view to streamline the regulatory submission procedure, the Central Drugs Standards Control... Read More