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Date: 2023-08-22 Category: Not Applicable State: Union Government Country: India

June Revised Drugs Alert List 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

  • The gazette notification lists drugs declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for June 2023 (Revised).

Key Changes

  • Two batches of Pantoprazole Gastro-Resistant Tablets IP (PAN*40) have been declared spurious.
  • Batch number 22440483, manufactured in Feb-22, expiry Jul-24.
  • Batch number 22441073, manufactured in Apr-22, expiry Sep-24.
  • Both batches were purportedly manufactured by ALKEM HEALTH SCIENCE, a unit of Alkem Laboratories Limited, Unit2, Samardung Karek Block, P.O.: Namthang, South Sikkim- 737137.
  • The reason for failure is the Assay of Drug Pantoprazole.
  • The actual manufacturer (as per label claim) informed that the impugned batches were not manufactured by them and are spurious.
  • The determination of spuriousness is subject to the outcome of investigation.

Impact Analysis

Patients/Consumers

  • Action Item: Public awareness campaigns to inform consumers about the identified spurious drugs and the importance of purchasing medications from reputable sources.

Alkem Laboratories Limited

  • Action Item: Conduct internal investigation to determine the source of the spurious drugs and implement measures to prevent future occurrences. Cooperate fully with regulatory authorities in their investigation.

Regulatory Authorities (RDTL, Controller)

  • Action Item: Conduct thorough investigation to identify the source and distribution network of the spurious drugs. Increase vigilance and testing of drugs in the market. Strengthen collaboration between regulatory agencies and pharmaceutical companies to combat counterfeiting.

Pharmaceutical Industry

  • Action Item: Implement robust anti-counterfeiting measures, including track-and-trace technologies, to ensure product authenticity. Enhance supply chain security to prevent the entry of spurious drugs into the market.

Key Entities Referenced

Pantoprazole Gastro-Resistant Tablets IP (PAN*40): A medication used to reduce stomach acid production. ALKEM HEALTH SCIENCE, A unit of Alkem Laboratories Limited: A pharmaceutical company purportedly manufacturing the drugs in question. They deny manufacturing the spurious batches. RDTL Controller Guwahati: Regional Drugs Testing Laboratory Controller, Guwahati - the entity that conducted the drug assay and identified the failure.
Official Source Record View Original Source →
See Full Document Text
Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of June, 2023 (Revised) S.No. Name of B.No. Date of Date of Manufactured by Reasons for Drawn by From Remarks Drugs/medical Manufa Expiry failure device/cosmetics cture 38. Pantoprazole 22440483 Feb-22 Jul-24 ALKEM HEALTH Assay of Drug RDTL The actual manufacturer Gastro- Resistant SCIENCE, A unit Pantoprazole Controller Guwahati (as per label claim) has Tablets IP of Alkem Department informed that the (PAN*40) Laboratories Bhagalpur impugned batch of the Limited, Unit2, product has not been Samardung Karek manufactured by them Block, P.O.: and that it is a spurious Namthang, South drug. Thus, the product is Sikkim- 737137 purported to be spurious, however, the same is subject to outcome of investigation. 40. PAN 40 22441073 Apr-22 Sep-24 ALKEM HEALTH Assay of Drug RDTL The actual manufacturer (Pantoprazole SCIENCE, A unit Pantoprazole Controller Guwahati (as per label claim) has Gastro- Resistant of Alkem Depertment informed that the Tablets I.P.) Laboratories Goalpara impugned batch of the Limited, Unit2, product has not been Samardung Karek manufactured by them Block, P.O.: and that it is a spurious Namthang, South drug. Thus, the product is Sikkim- 737137 purported to be spurious, however, the same is subject to outcome of investigation. Page 1 of 1

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