CDSCO Flags 4 Drug Batches as Suspected Spurious in February 2026 Alert
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued an alert concerning four drug batches, with preliminary findings indicating that the products may be spurious, subject to the outcome of ongoing investigations.
The batches under scrutiny include Betamethasone and Clioquinol Cream BP, Ursodeoxycholic Acid Tablets IP 300 mg, Clobetasol Propionate & Gentamicin Sulphate Cream, and Amoxycillin & Potassium Clavulanate Tablets IP.
According to official records, all four products carry the remark: “The product is purported to be spurious, however, the same is subject to outcome of investigation.”
Regulatory sources stated that the manufacturers mentioned on the labels are currently under investigation, with details listed as “Under Investigation” in the official report.
In their responses, the firms identified on the product labels have denied manufacturing the batches in question. As per label claims, the actual manufacturers clarified that the impugned batches had not been produced by them and have termed the products as spurious drugs.
In accordance with the Drug and Cosmetic Act, a drug shall be deemed to be spurious—
(a) if it is imported under a name which belongs to another drug; or
(b) if it is an imitation of, or a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
(c) if the label or the container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or
(d) if it has been substituted wholly or in part by another drug or substance; or
(e) if it purports to be the product of a manufacturer of whom it is not truly a product
The term “Spurious Drug” has been defined under Section 17-B of the Drugs and Cosmetics Act, 1940.
| S.No | Name of Product | Batch No | Manufacturing Dates | Manufacturer Details | Reporting Source | Reporting by Lab/State | Reporting Month & Year | Remarks |
|---|---|---|---|---|---|---|---|---|
| 1 | Betamethasone And Clioquinol Cream BP | K73G | Manufacturing Date: Nov-2025Expiry Date: Oct-2027 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | CDL, Kolkata | FEB-2026 | NSQ Remark: The product is purported to be spurious, however, the same is subject to outcome of investigationFirm Reply: The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. |
| 2 | Urseodeoxycholic Acid Tablets IP 300 MG | GTG2220A | Manufacturing Date: Jul-2025Expiry Date: Jun-2027 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | State Lab | SDTL, Assam | FEB-2026 | NSQ Remark: The product is purported to be spurious, however, the same is subject to outcome of investigationFirm Reply: The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. |
| 3 | Clobetasol Propionate & Gentamicin Sulphate Cream | IA00187A | Manufacturing Date: Jul-2025Expiry Date: Jun-2027 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | CDL, Kolkata | FEB-2026 | NSQ Remark: The product is purported to be spurious, however, the same is subject to outcome of investigationFirm Reply: The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. |
| 4 | Amoxycillin & Potassium Clavulanate Tablet IP | 25440617 | Manufacturing Date: Feb-2025Expiry Date: Jul-2026 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | State Lab | SDTL, Kolkata, WB | FEB-2026 | NSQ Remark: The product is purported to be spurious, however, the same is subject to outcome of investigationFirm Reply: The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. |
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