Reduced Custom Duty to nil and GST to 5% on three anti-cancer medicines, effective October 10, 2024, requiring price revisions by manufacturers
The National Pharmaceutical Pricing Authority (“NPPA”) has issued a Notification informing that the Department of Revenue, Government of India, has announced a […]
Pharmaceuticals Department notifies revisions to sub-scheme ‘Revamped Pharmaceutical Technology Upgradation Assistance Scheme’: Increases incentive cap and simplifies application process for Pharma MSMEs
Department of Pharmaceuticals has notified modifications under the sub-scheme “Revamped Pharmaceutical Technology Upgradation Assistance Scheme”. This is pursuant to the deliberations held […]
CDSCO invites public comments on Draft Guidelines for Good Clinical Practices till 12th October 2024
The Central Drugs Standard Control Organization (“CDSCO”) has invited comments/suggestions on draft Guidelines on the Good Clinical Practices (“Draft Guidelines”) till 12th […]
Pharmaceutical companies mandated to disclose free sample and continuing medical education /conference related expenses on UCPMP portal within two months of financial year-end
The Department of Pharmaceuticals has directed pharmaceutical companies to submit a declaration detailing disclosures about distribution of free samples and expenses related […]
Health Ministry prohibits the manufacture, sale or distribution of 156 Fixed Dose Combinations
The Ministry of Health and Family Welfare (MoHFW) has implemented an immediate ban on 156 fixed-dose combinations (FDCs), including drugs commonly used […]
CDSCO streamlines online application process for registration of cosmetics prior to import; restricts maximum number of products to 50 in single online application effective from 16th August, 2024
With a view to streamline the online filing process for applications related to the mandatory registration of cosmetics prior to import, including […]
Public comments invited on Draft Guidelines on Good Distribution Practices for Pharmaceutical Products till 9th September, 2024
The Central Drugs Control Standards Organization (CDSCO) has invited public comments on draft Guidelines on Good Distribution Practices for Pharmaceutical Products till […]
DCGI specifies select countries for considering waiver of clinical trials for five specific categories of new drugs
The Drugs Controller General India (“DCGI”) has identified specific countries under the Rule 101 of the New Drugs and Clinical Trials Rules […]
CDSCO mandates adoption of WHO Guidelines on Good Manufacturing Practices for vaccine and sterile product manufacturers
The Central Drugs Control Standards Organization (CDSCO) has recently issued a Circular directing all vaccine and sterile product manufacturers to implement various […]
CDSCO mandates online-only submissions in Form-44 for veterinary drugs through SUGAM portal, ending offline options
With a view to streamline the regulatory submission procedure, the veterinary division of the Central Drugs Standard Control Organization (“CDSCO”) has mandated […]
Union Health Ministry mandates registration of Clinical Research Organizations under New Drugs and Clinical Trials Amendment Rules, effective 1st April, 2025
The Union Health Ministry has notified the New Drugs and Clinical Trials (Amendment) Rules, 2024 (“Amendment Rules”), introducing mandatory registration for Clinical […]
NPPA revises ceiling price of Chloroquine (150mg) tablet price to Rs. 1.33 per tablet; manufacturers directed to align pricing with ceiling price
The National Pharmaceutical Pricing Authority (“NPPA”), after reviewing the Wholesale Price Index (WPI) at 0.00551% for the year 2024, has revised the […]