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
2026.08.14 G.S.R. 743(E)_Amendment in MD Rules, 2017 for introduction of Ninth Schedule and labelling requirements for sterilization activities
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 →2026.08.06 G.S.R. 713(E)_Notification for amendment under Rule 89 of Drugs Rules 1945, for obtaining licence under Form 29 for different categories falling under Form 25A, 25F, 28A, 28B, 28D, 28DA, 28E, 28F
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 →2026.07.30 G.S.R. 706(E)_Notification regarding Debarment of applicant for submitting misleading, or fake, or Fabricated Documents, information
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 →2026.06.11 S.O. 3068(E) to S.O. 3083(E)_ Prohibition of 16 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 →2026.07.08 G.S.R. 607(E)_Notification regarding restriction of sale of drug products containing alcohol content under 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 →2026.07.02 G.S.R. 561(E)_Notification for consideration of Navi Mumbai International Airport (NMIA) as authorized Airport for Drug Import, under the provision of Rule 43A of Drugs Rules 1945â
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 →2026.06.29 G.S.R. 530(E)_Notification regarding Inclusion of additional items under CLAA in 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 →2026.06.23 G.S.R. 515(E)_Draft notification regarding amendments under Medical Devices Rules 2017
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 →2026.06.23 G.S.R. 509(E)_ Draft notification regarding simplification of the process for obtaining test licences for import of drugs under Form 11 of the 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 →2026.06.22 G.S.R. 504(E)_Draft notification regarding submission of Periodic Safety Update Reports annually for subsequent years till the drug product is marketed in the 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 →2026.06.22 G.S.R. 505(E)_Draft notification regarding rationalization of shelf life under Rule 31 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 →2026.06.22 G.S.R. 506(E)_Notification regarding amendment under Drugs Rules to include more categories under Schedule H2â
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 →2026.06.11 S.O. 3068(E) to S.O. 3083(E)_ Prohibition of 16 FDC’s
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 →2026.06.09 G.S.R. 477(E)_Notification for Removal of Syrup exemption under schedule K in the 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 →2026.06.01 G.S.R. 444(E)_Notification for amendment in Schedule V w.r.t. unit of measurement of Folic Acid under the 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 →2026.05.22 G.S.R. 407(E)_Notification for Revision of testing fees under Schedule B and B1 of Drugs and Cosmetics Actâ
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 →2026.05.13 G.S.R. 377(E)_Notification for amendment in Schedule H1 for inclusion of Pregabalin and its drug formulations
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 →2026.04.21 G.S.R. 299(E)_ Draft Notification for amendment under Rule 89 of Drugs Rules 1945, for obtaining licence under Form 29 for different categories falling under Form 25A, 25F, 28A, 28B, 28D, 28DA, 28E, 28F
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 →2026.04.10_G.S.R. 269(E)_Draft Notification to amend certain provisions w.r.t. Medical Device Testing Fee under MDR, 2017
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 →2026.04.10_ G.S.R. 270(E)_Draft Notification to amend certain provisions under Medical Devices Rules, 2017 EU
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 →