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Date: 2023-12-20 Category: Not Applicable State: Union Government Country: India

Drug Alert for the Month of May – 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 is a drug alert for May 2022 (Revised), specifically a list of drugs declared as Not of Standard Quality/Spurious/Adulterated/Misbranded.
  • The alert identifies a specific batch of Dr. Reddy's Omeprazole and Domperidone (Delayed-Release) Capsules as potentially spurious.

Key Changes

  • Dr. Reddy's Laboratories Ltd. has informed authorities that batch E21004 of Omeprazole and Domperidone (Delayed-Release) Capsules was not manufactured by them.
  • Based on Dr. Reddy's statement, the identified batch is considered a spurious drug, pending further investigation.
  • The batch in question was manufactured in December 2021 and has an expiry date of December 2022.

Impact Analysis

Impact on Dr. Reddy's Laboratories Ltd.

  • Action Item: Dr. Reddy's should fully cooperate with the investigation, conduct an internal audit of their manufacturing and supply chain security, and implement measures to prevent future counterfeiting.

Impact on Regulatory Bodies (Drugs Control Department, RDTL Guwahati, Assam)

  • Action Item: Expedite the investigation, collaborate with Dr. Reddy's and other relevant agencies, and issue public advisories to alert consumers and healthcare professionals.

Impact on Consumers

  • Action Item: Consumers should be advised to check the batch number of their medication and report any suspicious products to the authorities. Healthcare professionals should be informed about the drug alert and advise patients accordingly.

Impact on Pharmaceutical Industry

  • Action Item: Pharmaceutical companies should invest in advanced anti-counterfeiting technologies, strengthen supply chain security, and collaborate with regulatory bodies to combat drug counterfeiting.

Key Entities Referenced

Dr. Reddy's Laboratories Ltd.: The company whose product (Omeprazole and Domperidone Delayed-Release Capsules) is suspected to be spurious. Omeprazole and Domperidone (Delayed-Release) Capsules: The specific drug product that is the subject of the drug alert. Drugs Control Department Assam: The regulatory body involved in identifying and reporting the spurious drug. RDTL Guwahati Assam: Regional Drugs Testing Laboratory, Guwahati, Assam
Official Source Record View Original Source →
See Full Document Text
Drug Alert for the Month of May – 2022 (Revised) List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of May – 2022 (Revised) S.No Name of Batch Date Date of Manufactured Reason for Drawn By From Remarks Drugs/medical No. of Expiry By failure device/cosmetics Manu factur e 18. Dr. Reddys The actual manufacturer (as per label claim) has Omeprazole Laboratories Ltd., informed that the impugned batch of the product has (Delayed-Release) Village Mauja Assay of Drugs Control not been manufactured by them and that it is a E21004 01/202 and Domperidone 12/2022 Thana, Baddi- Omeprazole and Department RDTL Guwahati spurious drug. Thus, the product is purported to be 19 1 (Sustained Release) 173205, Dist. Domperidone Assam spurious, however, the same is subject to outcome of Capsules Solan, Himachal investigation. Pradesh. Page 1 of 1

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