Drugs (Amendment) Rules, 2026 revise endotoxin testing standards, introduce competent person supervision in specified sale licences and clarify Schedule H exclusions
Ministry of Health and Family Welfare has notified the Drugs (Amendment) Rules, 2026 (“Amendment”) which amends the Drugs Rules, 1945 (“Principal Rules”). […]
Department of Pharmaceuticals amends UCPMP 2024; extends the time limit for submission of disclosure of marketing expenditure till 30th September 2025
The Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers has issued a circular notifying the Amendment to the Uniform Code for Pharmaceuticals […]
Amendment to labelling requirements under Drugs Rules, 1945; inclusion of excipients details
The Ministry of Health and Family Welfare has notified the Drugs (2nd Amendment) Rules, 2025, effective from 1st March 2026, bringing a […]
Department of Pharmaceuticals extends deadline for filing self-declaration and marketing expenditure disclosure under UCPMP 2024 for FY 2024–25
The Department of Pharmaceuticals has issued a circular extending the timeline for submission of self-declaration and marketing expenditure disclosure under the Uniform […]
CDSCO issues guidance document for export NOC for manufacture of unapproved/approved new drugs
The Central Drugs Standard Control Organisation (‘CDSCO’), has issued a Guidance Document for Issuance of No Objection Certificate (“NOC”) for the manufacture […]
CDSCO issues clarification regarding comprehensive permission for overprinting/stickering/stamping of imported drugs under Rule 104A of the Drugs and Cosmetics Rules, 1945
The Central Drugs Standard Control Organization (“CDSCO”), under the Directorate General of Health Services, Ministry of Health and Family Welfare, has issued […]
CDSCO issues revised guidance document for application of Export NOC for unapproved/approved new drugs to be obtained through Sugam Portal
The Central Drugs Standard Control Organisation (‘CDSCO’), has issued a revised Guidance Document on Export NOC with a list of alternate documents […]
CDSCO prohibits manufacture, sale and distribution of unapproved Fixed Dose Combinations (FDC) Drugs
The Central Drugs Standard Control Organisation (“CDSCO”) has issued a Circular highlighting concerns regarding certain Fixed Dose Combination (“FDC”) drugs that were […]
MoHFW notifies Drugs and Cosmetics (Compounding of Offences) Rules, 2025, provides for grant of immunity from prosecution through compounding of offences
The Ministry of Health and Family Welfare has notified the Drugs and Cosmetics (Compounding of Offences) Rules, 2025 (hereinafter “the Rules”), effective […]