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HomeCDSCO Guidelines for Safe Drug Disposal: A Sustainable Shift for Indian PharmaPharmaceuticals

Category: Pharmaceuticals

Compliance, Legal analysis, Pharmaceuticals

CDSCO Guidelines for Safe Drug Disposal: A Sustainable Shift for Indian Pharma

In a significant step towards overhauling the disposal practices of expired and unused drugs and with the aim of protecting human and […]

Lexplosion SolutionsSeptember 9, 20255 min read
Central, OPS, Pharmaceuticals

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 […]

Lexplosion SolutionsSeptember 5, 20251 min read
Central, OPS, 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 […]

Lexplosion SolutionsAugust 22, 20251 min read
Central, OPS, Pharmaceuticals

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 […]

Lexplosion SolutionsAugust 8, 20251 min read
Central, OPS, Pharmaceuticals

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 […]

Lexplosion SolutionsJuly 25, 20251 min read
Compliance, Legal analysis, Pharmaceuticals

CDSCO’s Export NOC 2.0: New format, tighter checks, faster clearances—are you compliant?

The Central Drugs Standard Control Organisation (“CDSCO”) has revised the process of issuing No Objection Certificates (NOC) for the export of unapproved/approved […]

Lexplosion SolutionsJuly 23, 20253 min read
Central, OPS, Pharmaceuticals

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 […]

Lexplosion SolutionsMay 30, 20251 min read
Central, OPS, Pharmaceuticals

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 […]

Lexplosion SolutionsMay 9, 20251 min read
Central, OPS, Pharmaceuticals

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 […]

Lexplosion SolutionsMay 2, 20251 min read
Central, OPS, Pharmaceuticals

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 […]

Lexplosion SolutionsMay 2, 20251 min read

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