Union Health Ministry mandates registration of Clinical Research Organizations under New Drugs and Clinical Trials Amendment Rules, effective 1st April, 2025 by Lexplosion Solution | Oct 9, 2024 | Central, OPS, PharmaceuticalsThe Union Health Ministry has notified the New Drugs and Clinical Trials (Amendment) Rules, 2024... Read More
Pharmaceutical companies mandated to disclose free sample and continuing medical education /conference related expenses on UCPMP portal within two months of financial year-end by Lexplosion Solution | Oct 9, 2024 | Central, OPS, PharmaceuticalsThe Department of Pharmaceuticals has directed pharmaceutical companies to submit a declaration... 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