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 […]
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 […]