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Date: 2022-12-08 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of Feb 2022 (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 gazette notification, titled 'Drug Alert February- 2022', lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for the month of February 2022.
  • The notification specifically highlights the drug Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg Tablets IP (TELMA H TABLETS) due to a failure in assay.

Key Changes

  • Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg Tablets IP (TELMA H TABLETS), bearing batch number 18200994, manufacturing date 10/2020 and expiry date 09/2023, manufactured allegedly by M/s. Glenmark Pharmaceuticals Ltd., Samlik, Marchak, Industrial Growth Centre, East Sikkim, Sikkim-737135, has been declared as Not of Standard Quality due to failure in the assay test.
  • The drug was drawn from Delhi.
  • The Drugs Controller, Sikkim, informed that during investigation it was concluded that the product is not genuine.

Impact Analysis

Glenmark Pharmaceuticals Ltd.

  • Action Item: Review and strengthen quality control processes to prevent future occurrences.

Patients and Consumers

  • Action Item: Public awareness campaigns may be necessary to inform consumers about the issue and encourage them to report any adverse effects.

Regulatory Authorities (Drugs Controller, Sikkim & Delhi)

  • Action Item: Review and update regulations and guidelines to prevent future occurrences.

Pharmacies and Distributors

  • Action Item: Verify the authenticity and quality of pharmaceutical products from all suppliers.

Key Entities Referenced

Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg Tablets IP (TELMA H TABLETS): A pharmaceutical product used to treat hypertension. M/s. Glenmark Pharmaceuticals Ltd.: The manufacturer of the drug in question, located in Sikkim. Drugs Controller, Sikkim: The regulatory authority that conducted the investigation and reported the findings. RDTL: Reference Drug Testing Laboratory
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 Feb– 2022 (Revised) Drug Alert February- 2022 Sl. Name of the Product Manufactured Reason Drawn From Remarks no. drugs Details By for By Failure 23. Telmisartan 40 mg B. No.: Allegedly Mfd by: Assay of Drug RDTL Drugs Controller, and 18200994 M/s. Glenmark Telmisart Control Chandi Sikkim, informed Hydrochlorothiazid Mfg dt: Pharmaceuticals an Departm garh that during e 10/2020 Ltd. ent investigation it was 12.5 mg Tablets IP Exp dt: Samlik, Marchak, Delhi concluded that the (TELMA H 09/2023 Industrial Growth product is not TABLETS) Centre, East genuine. Sikkim, Sikkim-737135

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