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 […]
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 […]
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) […]
DoT notifies Telecommunications (Right of Way) Rules, 2024; prescribes compliance obligations for establishment, operation and maintenance of Telecommunication Network
The Department of Telecommunications (“DoT”), pursuant to the provisions of the Telecommunications Act, 2023 and in supersession of the Indian Telegraph Right […]
Commerce Ministry notifies Safety of Household, Commercial and Similar Electrical Appliances (Quality Control) Order, 2024
The Ministry of Commerce and Industry (“Ministry”) has notified the Safety of Household, Commercial and Similar Electrical Appliances (Quality Control) Order, 2024 […]
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 […]
Ministry of Finance notifies Accessibility Standards and Guidelines for infrastructure and services in Financial Institutions, aligning with Rights of Persons with Disabilities Act, 2016
The Ministry of Finance (Department of Financial Services) has notified the “Accessibility Standards and Guidelines for infrastructure and services in Financial Institutions”, […]
Ministry of Steel notifies the Steel and Steel Products (Quality Control) Order, 2024 in supersession of existing quality control regime; prescribes enforcement date of applicable standards for steel and steel products
In continuation to what we reported earlier (please refer to e-mail in trail), the Ministry of Steel (“Ministry”) has notified the Steel […]