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 […]
TRAI mandates compliance reports and 24 hour network outage reports from service providers from 1st October, 2024
The Telecom Regulatory Authority of India (“TRAI”) has directed all telecom service providers to submit report of compliance with its new quality […]
Ministry of Corporate Affairs amends Indian Accounting Standard Rules, Insurers permitted to use Ind AS 104 for Consolidated Financial Statements until IRDAI notifies Ind AS 117
The Ministry of Corporate Affairs (“MCA”) has notified Companies (Indian Accounting Standards) Third Amendment Rules, 2024 (“Amendment Rules, 2024”) to amend Companies […]
Timeline for filing annual returns by PIBOs and PWPs under the Plastic Waste Management Rules, 2016 for FY 2023-24 stands extended till 30th November, 2024
The Central Pollution Control Board extended the timeline for filing of annual returns by Producers, Importers and Brand Owners (“PIBOs”) and Plastic […]
MoEFCC notifies Ecomark Rules, 2024; prescribes condition, procedure, use etc. of Ecomark certification on various products
Pursuant to what we have reported earlier (please refer to the e-mails in trail), the Ministry of Environment, Forest, and Climate Change […]
FSSAI enables instant (Tatkal) issuance of licenses / registration in certain categories such as wholesalers, distributors, retailers, transporters, storage without atmospheric control etc.; step towards Ease of Doing Business
Pursuant to the Update reported earlier (please refer to the email in trail), the Food Safety and Standards Authority of India (“FSSAI”) […]
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 […]