Home› India› Ministry of Health and Family Welfare› Drug Alert list for month of April 2022 (Revised)...
Date: 2022-06-15 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of April 2022 (Revised)

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

What it means

  • This is a drug alert notification for April 2022 (Revised), issued by a government authority, listing drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded.
  • The notification specifically identifies one drug product that failed quality tests.

Key Changes

  • Ursodeoxycholic Acid Tablets IP 300 mg (UDILIV-300), Batch No: 250923D7, manufactured by M/s Abbott India Limited, has been declared as 'Spurious'.
  • The reason for failure is related to Identification and Assay, as determined by Drugs RDTL Control, Guwahati.
  • The manufacturer, Abbott India Limited, has stated that the impugned batch was not manufactured by them, indicating it is a spurious drug. This is subject to final investigation by the Drugs Control Department Assam.

Impact Analysis

Impact on Patients/Consumers

  • Advise patients who have consumed Ursodeoxycholic Acid Tablets IP 300 mg (UDILIV-300), Batch No: 250923D7 to consult their healthcare provider.

Impact on M/s Abbott India Limited

  • Abbott India Limited should implement measures to prevent counterfeiting and ensure the integrity of their supply chain.

Impact on Pharmacies and Retailers

  • Pharmacies and retailers should cooperate with the investigation by providing information about the source of the spurious drug.

Impact on Regulatory Authorities

  • The Drugs Control Department Assam should publicize the findings of their investigation to inform the public and deter future offenses.

Suggested Action Items

  • Strengthen collaboration between regulatory authorities, pharmaceutical companies, and law enforcement agencies to combat drug counterfeiting.

Key Entities Referenced

M/s Abbott India Limited: The manufacturer of the Ursodeoxycholic Acid Tablets IP 300 mg (UDILIV-300) batch in question. They have denied manufacturing the specific batch. Drugs RDTL Control, Guwahati: The drug testing laboratory that identified the Ursodeoxycholic Acid Tablets IP 300 mg as failing identification and assay tests. Drugs Control Department Assam: The regulatory authority responsible for investigating the spurious drug and taking appropriate action. Ursodeoxycholic Acid Tablets IP 300 mg (UDILIV-300): The specific drug product that has been declared as spurious in this notification. Batch No: 250923D7.
Official Source Record View Original Source →
See Full Document Text
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of April 2022 (Revised) Drug Alert April-2022 Sl. Name of the Product Manufactured Reason for Drawn By From Remarks No. Drugs Details By Failure 17 Ursodeoxycholi Batch No: M/s Abbott Identification Drugs RDTL The actual c Acid Tablets 250923D7 India Limited. and Assay Control Guwahati manufacturer IP 300 mg Mfg Dt.- L-18/19, Department (as per label (UDILIV-300) 01/2021 Verna Assam claim) has Exp. Dt.- Industrial declared the 05/2023 Area, Verna, impugned batch Salcette, Goa- to be not 403722 manufactured by them and that it is a spurious drug. However, the same is subject to outcome of final investigation by the concerned Investigating official of Drugs Control Department Assam

Continue your research

Related Documents from Ministry of Health and Family Welfare