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 […]
Goods and Services Tax Network issues draft manual on Invoice Management System
Goods and Services Tax Network (“GSTN”) in its recent update has issued a detailed draft manual on Invoice Management System (IMS) in […]
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 […]
Ministry of Heavy Industries updates Frequently Asked Questions (‘FAQs’) on Electrical Equipment (Quality Control) Order w.r.t product testing and usage
The Ministry of Heavy Industries has updated the Frequently Asked Questions document (“FAQs”) addressing inquiries related to the Electrical Equipment (Quality Control) […]