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 […]
Public comments invited on proposed amendments to First and Second Schedule of the Drugs and Cosmetics Act till 12th April, 2023
The Ministry of Ayush has invited objections and suggestions on proposed amendments to Schedule I and II of the Drugs and Cosmetics […]
CDSCO issues FAQ for implementation Barcode requirement on the label of 300 brands of drugs
Central Drugs Standard Control Organization has issued a FAQ for implementation of the requirement of Barcode or Quick Response (QR) Code on […]
NPPA extends date for filing quarterly returns for quarter ended September, 2022 and MRP revisions of scheduled and non-scheduled drugs and medical devices till 31st December, 2022
On receiving representations from industry associates National Pharmaceutical Pricing Authority has extended the last date for filing certain statutory forms under Drugs […]
CDSCO issues a list of spurious, adulterated, misbranded, or non-standard quality drugs, medical devices and cosmetics for the month of September, 2022
Central Drugs Standard Control Organization (“CDSCO”) has issued a list of Drugs, Medical Devices, and Cosmetics which have been declared as Not […]
Ministry of Health releases revised National List of Essential Medicines; 34 new drugs added to list and 26 drugs deleted
The Union Health Ministry has released a revised list of medicines and drugs under the National List of Essential Medicines, 2022 (“NLEM […]
National Pharmaceutical Pricing Authority fixes the retail price for certain formulations; overcharged amount (with interest) to be imposed for non-compliance
The National Pharmaceutical Pricing Authority (“NPPA”) has notified the list of retail price (exclusive of Goods and Service Tax), with respect to […]