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Date: 2023-10-19 Category: Not Applicable State: Union Government Country: India

Drug Alert for the Month of March 2023 (Revised)

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 revised drug alert for March 2023, specifically identifying drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded.

Key Changes

  • Telmisartan 40 mg and Amlodipine 5 mg Tablets IP (Telma-AM Tablets) with Batch No. 18220076, manufactured in January 2022 and expiring in December 2024, is listed as a potentially spurious drug.
  • The stated manufacturer, Glenmark Pharmaceuticals Ltd., has reported that the batch was not manufactured by them.
  • The reason for failure is the dissolution of Telmisartan.
  • The sample was drawn by the Control Department RDTL Chandigarh from East Sikkim-737135.
  • The spurious nature of the drug is subject to the outcome of investigation.

Impact Analysis

Consumers

  • Action Item: Raise awareness about the specific batch of Telma-AM tablets identified as potentially spurious. Advise consumers to check the batch number and consult with their healthcare provider if they have consumed the affected batch.

Glenmark Pharmaceuticals Ltd.

  • Action Item: Cooperate fully with the investigation to identify the source of the spurious drug and prevent future occurrences. Issue a public statement clarifying their position and reassuring consumers about the authenticity of their products.

Regulatory Authorities (Control Department RDTL Chandigarh)

  • Action Item: Expedite the investigation to determine the origin and extent of the spurious drug distribution. Enhance collaboration with other regulatory agencies and law enforcement to combat pharmaceutical counterfeiting.

Pharmacies and Distributors

  • Action Item: Immediately quarantine and remove the affected batch of Telma-AM tablets from their inventory. Verify the authenticity of pharmaceutical products received from suppliers and report any suspicious activity to the authorities.

Key Entities Referenced

Telmisartan 40 mg and Amlodipine 5 mg Tablets IP (Telma-AM Tablets): A combination drug used to treat hypertension. Glenmark Pharmaceuticals Ltd.: The pharmaceutical company whose name is falsely associated with the spurious drug batch. Control Department RDTL Chandigarh: The drug regulatory authority that drew the sample and is responsible for investigating the matter.
Official Source Record View Original Source →
See Full Document Text
Drug Alert for the Month of March – 2023 (Revised) List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of March – 2023 (Revised) S.No Name of Batch No. Date of Date of Manufacture Reason for Drawn By From Remarks Drugs/medica Manufa Expiry d By failure l cture device/cosme tics 32. The actual manufacturer (as per label claim) Telmisartan 40 Glenmark has informed that the impugned batch of the mg and Drug Pharmaceuti product has not been manufactured by them Amlodipine 5 B.No. Mfg. Dt. Exp.Dt. Dissolution of Control RDTL cals Ltd., and that it is a spurious drug. Thus, the product mg Tablets IP 18220076 01/2022; 12/2024; Telmisartan Department Chandigarh East Sikkim- is purported to be spurious, however, the same (Telma-AM Delhi 737135. Tablets); is subject to outcome of investigation. Page 1 of 1

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