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Date: 2024-03-20 Category: Not Applicable State: Union Government Country: India

Drug Alert for the Month of Revised Jan 2024

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 January 2024 (Revised), listing drugs, medical devices, vaccines, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded.
  • The notification specifically identifies one drug, Levetiracetam Tablets IP (Levipil 500), batch number SIE1003A, manufactured in April 2023 and expiring in March 2025, as potentially spurious.

Key Changes

  • Levetiracetam Tablets IP (Levipil 500), batch number SIE1003A, manufactured by Sun Pharma Laboratories Ltd., is suspected to be a spurious drug.
  • The actual manufacturer, Sun Pharma, has stated that they did not manufacture the identified batch.
  • The reason for failure is dissolution, and the product was drawn by CDSCO (North Zone), Kolkata, from Ghaziabad.
  • The spurious nature of the drug is subject to further investigation.

Impact Analysis

Sun Pharma Laboratories Ltd.

  • Internal investigation to determine how the spurious product was labeled with their name and prevent future occurrences.

CDSCO (Central Drugs Standard Control Organization)

  • Communicate investigation findings and any subsequent actions to the public to maintain transparency and confidence in the drug supply.

Patients/Consumers

  • Consult healthcare provider if they have consumed the specified batch of Levetiracetam Tablets IP (Levipil 500).

Pharmacies and Retailers

  • Cooperate with CDSCO and other regulatory authorities in the investigation.

Key Entities Referenced

CDSCO (Central Drugs Standard Control Organization): The national regulatory body for pharmaceuticals and medical devices in India. Sun Pharma Laboratories Ltd.: The labeled manufacturer of the potentially spurious Levetiracetam Tablets IP (Levipil 500) batch SIE1003A, who claims they did not manufacture the batch. Levetiracetam Tablets IP (Levipil 500): The drug identified as potentially spurious in the notification. Batch number SIE1003A.
Official Source Record View Original Source →
See Full Document Text
Drug Alert for the Month of January – 2024 (Revised) List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of January– 2024 (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) 09. The actual manufacturer (as per label claim) has informed that the impugned batch of the Sun Pharma CDSCO product has not been Levetiracetam Laboratories Ltd., Plot (North CDL, manufactured by them and that Tablets IP SIE1003A 04/2023 03/2025 No. 107-108, Namli Dissolution Zone), Kolkata it is a spurious drug. Thus, the (Levipil 500) Block, P.O. Ranipool, Ghaziabad product is purported to be Sikkim - 737 135. spurious, however, the same is subject to outcome of further investigation. Page 1 of 1

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