Health Ministry restricts the manufacture, sale or distribution of two Fixed Dose Combinations of Naproxen subject to certain conditions
The Ministry of Health and Family Welfare (“MoHFW”) has implemented restriction on the manufacture, sale or distribution of the following Fixed Dose […]
Health Ministry permits import of drugs through Cochin and Thiruvananthapuram airports
The Ministry of Health and Family Welfare (“MoHFW”) has notified the Drugs (Third Amendment) Rules, 2024. The changes in the final Notification […]
Department of Pharmaceuticals mandates self-declaration for compliance with new Uniform Code for Pharmaceutical Marketing Practices (UCPMP) by 30th June, 2024
The Department of Pharmaceuticals has directed pharmaceutical companies to submit self-declaration of adherence to the Uniform Code for Pharmaceutical Marketing Practices 2024 […]
Stakeholders in medical devices sector urged by CDSCO to ensure timely payment of retention fees to maintain validity of licenses and certificates
The Central Drugs Standard Control Organisation (“CDSCO”) has reiterated that licenses for manufacturing or importing medical devices, as well as registration certificates […]
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
The Central Drugs Standard Control Organization (CDSCO) has issued a Circular in response to representations from various associations and stakeholders to ensure […]
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
The Central Drugs Control Standards Organization (CDSCO) has communicated to drug controllers of all States and Union Territories regarding the withdrawal of […]
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 the New Drugs and Clinical Trial Rules, […]
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 refer to e-mails in trail for details), […]
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 Health has amended the Drugs Rules, […]
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 Organisation (“CDSCO”) has notified that applications of Period […]
Dial Schedule M: India’s drug manufacturing practices to undergo major overhaul
If you are a pharmaceutical company in India with a turnover of more than Rs. 250 crores, you only have till July […]
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
Ministry of Health and Family Welfare has issued a Notification dated February 5, 2024, revoking an earlier Notification dated February 17, 2017 […]