CDSCO Flags Ursodeoxycholic Acid Tablets Batch as Purportedly Spurious
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued an alert regarding a batch of Ursodeoxycholic Acid Tablets IP after preliminary findings indicated that the product may be spurious, subject to the outcome of an ongoing investigation.
According to the latest drug alert report, the batch under scrutiny is Ursodeoxycholic Acid Tablets IP bearing batch number GTF2281A, manufactured in August 2024 with an expiry date of July 2026.
The product was reported by Central Drugs Laboratory (CDL), Kolkata, under CDSCO Labs in the April 2026 report. Regulatory records mention the manufacturer details as “Under Investigation.”
The official remark in the report stated, “The product is purported to be spurious, however, the same is subject to outcome of investigation.”
As per the firm’s response, the actual manufacturer mentioned on the label claim has informed authorities that the impugned batch was not manufactured by them and has classified the product as a spurious drug.
CDSCO has initiated further investigation into the matter to determine the source and authenticity of the batch.
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 | Ursodeoxycholic Acid Tablets IP | GTF2281A | Manufacturing Date: Aug-2024Expiry Date: Jul-2026 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | CDL, Kolkata | APR-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. |
