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 […]
Enhanced fines and reduced imprisonment for violations under Pharmacy Act 1948 effective 31st December, 2024: Health Ministry confirms implementation date for amendments under Jan Vishwas Act
The Ministry of Health and Family Welfare has appointed 31st December, 2024 as the date on which the amendments pertaining to the […]
Ministry of Health and Family Welfare prohibits the manufacture, sale, and distribution of S(+) Etodolac and Paracetamol Combination over safety concerns
The Health Ministry has prohibited the manufacture, sale, and distribution of the fixed-dose combination of S (+) Etodolac and Paracetamol for human […]
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 […]