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Date: 2024-02-21 Category: Not Applicable State: Union Government Country: India

Drug Alert for the Month of Revised Dec 2023

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

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Executive Summary & Key Takeaways

What it means

  • This is a drug alert notification for December 2023 (Revised) identifying drugs, medical devices, vaccines, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded.
  • The notification specifically identifies one drug, Pantoprazole Gastro-resistant Tablets IP (PAN-40), Batch No. 22442076, as potentially spurious.

Key Changes

  • The alert identifies Pantoprazole Gastro-resistant Tablets IP (PAN-40), Batch No. 22442076, manufactured in July 2022 with an expiry date of December 2024, as potentially spurious.
  • The actual manufacturer, ALKEM HEALTH SCIENCE, Unit-2, has stated that they did not manufacture the specified batch.
  • The drug was drawn by the State Inspector of Drugs, Guwahati, from Bihar.
  • The reason for failure is that the product is purported to be spurious, pending further investigation.

Impact Analysis

Patients/Consumers

  • Action Item: Public awareness campaign to inform consumers about the spurious drug and to advise them to check batch numbers and consult healthcare professionals if they have consumed the drug. Strengthen post-market surveillance to prevent such incidents.

Alkem Health Science

  • Action Item: Conduct internal investigation to identify the source of the spurious drug and implement measures to prevent future occurrences. Cooperate fully with regulatory authorities in their investigation. Enhance supply chain security measures.

Regulatory Authorities (State Inspector of Drugs, Guwahati; RDTL)

  • Action Item: Conduct thorough investigation to identify the source and distribution network of the spurious drug. Implement stricter penalties for manufacturers and distributors of spurious drugs. Enhance collaboration between state and central drug control authorities.

Pharmaceutical Industry

  • Action Item: Industry-wide collaboration to develop and implement advanced anti-counterfeiting technologies. Promote ethical practices and transparency in the pharmaceutical supply chain. Invest in public awareness campaigns to educate consumers about genuine and spurious drugs.

Key Entities Referenced

Pantoprazole Gastro-resistant Tablets IP (PAN-40): A medication, Batch No. 22442076, identified as potentially spurious. ALKEM HEALTH SCIENCE, Unit-2: The actual manufacturer (as per label claim) who has denied manufacturing the spurious batch. State Inspector of Drugs, Guwahati: The entity that drew the sample of the drug from Bihar. RDTL: Reference Drug Testing Laboratory
Official Source Record View Original Source →
See Full Document Text
Drug Alert for the Month of December – 2023 (Revised) List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of December– 2023 (Revised) S.No Name of Batch No. Date of Date of Manufactured By Reason for Drawn By From Remarks Drugs/medical Manufa Expiry failure (Name of device/cosmetics cture the Laboratory) 70. The actual manufacturer (as per label claim) has informed that the Pantoprazole ALKEM HEALTH impugned batch of the product has State Gastro-resistant SCIENCE, Unit-2, not been manufactured by them Jul- Inspector of RDTL, Tablets IP (PAN- 22442076 Dec-2024 Samardung, Karek Assay and that it is a spurious drug. Thus, 2022 Drugs, Guwahati 40) Block, PO- Namthang, the product is purported to be Bihar South Sikkim737137 spurious, however, the same is subject to outcome of further investigation. Page 1 of 1

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