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
Recent official updates
Draft addition of four drugs to Schedule H1
Summary: A draft amendment proposes adding four further drugs to Schedule H1.
Outcome / action: Stakeholders should review the draft and the period allowed for comments.
Practical impact: Assess prescription, warning-label and sales-register implications.
Open official source →Draft revision of medical-device testing fees
Summary: A draft amendment proposes changes to medical-device testing fees.
Outcome / action: Comments may be submitted within the period stated in the Gazette notification.
Practical impact: Device businesses should assess future testing and budgeting effects.
Open official source →Draft simplification of Form 11 requirements
Summary: A draft amendment proposes simplification of regulatory requirements involving Form 11.
Outcome / action: The proposal remains subject to the statutory consultation process.
Practical impact: Review import/test workflows and prepare comments where relevant.
Open official source →Draft annual PSUR reporting amendment
Summary: A draft amendment proposes annual periodic safety update reporting changes.
Outcome / action: Stakeholders should verify the proposed reporting cycle and consultation deadline.
Practical impact: Pharmacovigilance teams should assess reporting calendars and systems.
Open official source →Draft shelf-life amendment under Rule 31
Summary: A draft notification proposes changes relating to shelf life under Rule 31.
Outcome / action: The proposal is open to the process and timetable stated in the official notice.
Practical impact: Review stability data, labelling and product-registration consequences.
Open official source →Pregabalin added to Schedule H1
Summary: The notification adds pregabalin to Schedule H1 controls.
Outcome / action: Schedule H1 prescription, warning and record-keeping requirements apply as notified.
Practical impact: Update pharmacy controls, labels, training and sales registers.
Open official source →Medical Device Alert dated 08 May 2023
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 →Medical Device Alert dated 08 May 2023
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 alert discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority document before publication or compliance action.
Open source record →Medical Device Alert dated 29 Dec 2022
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 →Medical Device Alert dated 29 Dec 2022
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 alert discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority document before publication or compliance action.
Open source record →G.S.R 778 (E) dated 14 Oct 2022 regarding the New Drugs and Clinical Trials (Third Amendment) Rules 2022
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 →G.S.R. 777(E) 14 Oct 2022 Final notification for exemption of non sterile and non measuring Class A medical devices from licensing regime
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 →GSR 754 (E) 30-09-2022 sale of medical device retail and wholesale
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 →Medical Device Alert date 21 July 2022
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 →Medical Device Alert date 21 July 2022
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 alert discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority document before publication or compliance action.
Open source record →Medical Device Alert date 21 June 2022
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 →Medical Device Alert date 21 June 2022
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 alert discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority document before publication or compliance action.
Open source record →Medical Device Alert date 14 June 2022
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 →Medical Device Alert date 14 June 2022
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 alert discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority document before publication or compliance action.
Open source record →Medical Devices Alert 8 November 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 →Medical Devices Alert 8 November 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 alert discovered automatically; legal and factual verification is pending.
Practical impact: Review the linked authority document before publication or compliance action.
Open source record →NSQ Vi-Conjugate Typhoid Vaccine Batch No.TC010915 and Batch No. TC010417 of M/s Bio Med Pvt Ltd dated 14-03-2018
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 →2018.07.11_Draft GSR 629 (E)Information to be uploaded on SUGAM by license
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 January 2018
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 →2018.07.11_S.O.3400 (E)_ Notification of Medical Device Testing Officers (MDTO)
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 →IN-VITRO DIAGNOSTIC ALERT FOR PRODUCT ” BBL(TM) MGIT(TM) Mycobacteria Growth Indicator Tube
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 →