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)
With 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
Pursuant 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
In 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
With a view to streamline the regulatory submission procedure, the Central Drugs Standards Control... Read More