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 Anum Ahmed | 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 Anum Ahmed | 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 Anum Ahmed | 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 Anum Ahmed | Feb 29, 2024 | Central, OPS, PharmaceuticalsWith a view to streamline the regulatory submission procedure, the Central Drugs Standards Control... Read More
Dial Schedule M: India’s drug manufacturing practices to undergo major overhaul by Lexplosion | Feb 28, 2024 | Compliance, Legal analysis, PharmaceuticalsIf you are a pharmaceutical company in India with a turnover of more than Rs. 250 crores, you only... Read More
Health Ministry permits the sale of Oseltamivir Phosphate and Zanamivir akin to Schedule H1 drugs, with restrictions on sale and export regulated by the Government and DCGI by Anum Ahmed | Feb 12, 2024 | Central, OPS, PharmaceuticalsMinistry of Health and Family Welfare has issued a Notification dated February 5, 2024, revoking... Read More