CDSCO flags PAN-D, TAXIM-O 200, Rosuvas 10 samples as spurious in October 2024 alert
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has declared three drugs, Pantoprazole Gastro-resistant and Domeperiodone Prolong Released Capsules IP (PAN-D), Cefixime Tablets IP (TAXIM-O 200), and Rosuvastatin Tablets IP (Rosuvas 10), as spurious for the month of October 2024.
The declaration is part of CDSCO's monthly surveillance initiative to identify counterfeit or non-compliant pharmaceutical products and inform stakeholders about the risks associated with these batches.
The flagged samples were collected by drug inspectors in Bihar and Kolkata. The spurious nature of these three drugs is under investigation, and their final status will depend on the outcome of regulatory inquiries.
The first drug, Pantoprazole Gastro-resistant and Domperidone Prolong Released Capsules IP (PAN-D), associated with batch number 23444296, was manufactured in December 2023 with an expiry date of November 2025. The drug was flagged due to issues with identification and assay, with the stated manufacturer denying involvement, suggesting counterfeit activity.
The second drug, Cefixime Tablets IP (TAXIM-O 200), from batch number 23460072, had a manufacturing date of January 2023 and an expiry in December 2024. It failed regulatory standards for dissolution and assay, with the manufacturer disassociating from the batch, further indicating its spurious nature.
The third drug, Rosuvastatin Tablets IP (Rosuvas 10), under batch number SIE0116A, was produced in February 2023 with a listed expiry of July 2025. Like the other two, it failed dissolution and assay tests, and the manufacturer denied responsibility for the batch.
In all three cases, the manufacturers disclaimed producing the flagged batches, raising serious concerns about counterfeit drug circulation.The three drug samples picked by the Bihar Drugs Control Authority in were manufactured by unauthorised and unknown manufacturers, using brand name owned by another company.
"An investigation has been initiated into the matter," Union Health Ministry was quoted as saying by PTI on Friday.
Below is the detailed list of flagged drugs for October 2024:
| S.No. | Name of Drug/Medical Device/Cosmetic | Batch No. | Manufacture Date | Expiry Date | Manufactured By | Reason for Failure | Remarks on Spurious Nature |
|---|---|---|---|---|---|---|---|
| 1 | Pantoprazole Gastro-resistant and Domeperiodone Prolong Released Capsules IP (PAN-D) | 23444296 | 12/2023 | 11/2025 | Under Investigation | Identification and Assay | The actual manufacturer denies making this batch; deemed spurious, pending investigation. |
| 2 | Cefixime Tablets IP (TAXIM-O 200) | 23460072 | 01/2023 | 12/2024 | Under Investigation | Dissolution and Assay | Manufacturer denies responsibility; spurious status under investigation. |
| 3 | Rosuvastatin Tablets IP (Rosuvas 10) | SIE0116A | 02/2023 | 07/2025 | Under Investigation | Dissolution and Assay | Manufacturer disclaims batch; declared spurious, subject to investigation. |
Under Section 17-B of the Drugs and Cosmetics Act, 1940, a drug is classified as spurious if it is falsely manufactured under the name of another drug or imitates or substitutes another drug in a deceptive way. Additionally, it is considered spurious if it bears false labeling or claims to be produced by a fictitious manufacturer. The law also includes cases where the drug is wholly or partially substituted with another substance or falsely purports to be the product of a specific manufacturer.
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