Pharma Legal, Enforcement & Alert Intelligence
Source-linked judgments, compliance and enforcement developments, and regulatory alerts.
Alert monitor last checked: 2026-09-05 18:25:31
Court Judgments & Legal Opinions
Pharma-related cases, judgments, legal opinions and precedents.
148 recordsOpen Section →02
Compliance & Enforcement
Compliance requirements, inspections, violations, enforcement actions and recalls.
27 recordsOpen Section →03
Legal / Regulatory Alerts
Important legal and regulatory developments requiring attention.
503 recordsOpen Section →
Legal / Regulatory Alerts · 503 visible records
2025.08.27_G.S.R. 587(E)_Draft Notification for application of unapproved drugs for conduct of BA BE studies for export purpose under NDCT Rules 2019
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2025.08.27_G.S.R. 588(E)_Draft Notification about changes to requirements of Test license under NDCT Rules 2019
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2025.08.18_G.S.R. 554(E)_Inclusion of details of excipient on every strip of medicines under Rule 96, in sub-rule (7) of Drugs Rules, 1945
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2025.08.01_S.O. 3551(E)_Appointment of Compounding Authority under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2025.07.29_G.S.R. 513(E)_Certain amendments in Cosmetics Rule 2020
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2025.05.28_G.S.R. 345(E)_Draft notification for amendment in certain Drugs Rules (Related to Rule 121 â Test for Pyrogen, Footnote of Schedule H, condition of license under Form 20B, 20BB, 21B, 21BB, inclusion of name of competent person in Form 20G)
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2025.03.27_S.O. 203(E)_Notification of Government Analysts at National Institute of Biologicals, Noida
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2025.03.12_S.O. 1159(E)_Reconstitution of Drugs Technical Advisory Board (DTAB)
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2025.02.11 G.S.R. 127(E) Notification reg Extension of timeline for implementation of Schedule M
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2025.01.30_ S.O. 558(E)_Notification of IVRI Veterinary Government Analyst
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2025.01.04_G.S.R. 10(E)_ Notification for Extension of Schedule M
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2025.01.06_G.S.R. 11(E)_Corrigendum to G.S.R 10(E) dated 04.01.2025 reg Extension of Schedule M
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2024.12.10_MDR_S.O. 5331(E)_reg Notification of Medical Device Testing Officers (MDTO) for Laboratories
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2024.09.25 S.O. 4197(E) Amendment for Government Analysts at CDL Kolkata
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2024.08.12__DR_S.O. 3285(E) to 3440(E)_ Prohibition of 156 FDCs
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2024.08.12__DR_S.O. 3266(E) to 3267(E)_ Restriction of FDC (Naproxen + Esomeprazole and Naproxen + Pantoprazole)
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2026.08.18 S.O. 4595(E)_Prohibition of all formulations of FDC containing Chlorpheniramine Maleate and Phenylephrine HCl in children below four years of age
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →Recall of OZURDEX (Dexamethasone Intravitreal Implant 0.7mg)
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →2026.08.19 G.S.R 745(E)_Draft notification for inclusion of additional four drugs in Schedule H1
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →Drug Alert list for month of Feb 2021
Summary: Automatically discovered on the official CDSCO Alerts page. Open and verify the authority document for product, batch, manufacturer, scope and required action.
Outcome / action: Official-source item discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority record before publication or compliance action.
Open source record →