CDSCO Flags Sporlac-DS Batch as Suspected Spurious in September 2026 Alert
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has flagged a batch of Lactic Acid Bacillus Tablets (120 M), bearing the brand name Sporlac-DS, as purportedly spurious, subject to the outcome of an investigation.
The product was included in the September 2026 drug alert following a report from the Central Drugs Laboratory (CDL), Kolkata, under CDSCO Labs.
The batch under scrutiny bears number BDS25003, with a manufacturing date of February 2025 and an expiry date of January 2027. The alert lists both “Manufacturer Name” and “Manufactured By” as “Under Investigation.”
The official remarks state, “The product is purported to be spurious. However, the same is subject to outcome of investigation.”
According to the firm’s response recorded in the alert, the actual manufacturer named on the product label informed the authorities that the impugned batch had not been manufactured by it and that the product was a spurious drug.
"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," the alert stated.
The entry therefore concerns the authenticity of the specific batch bearing the Sporlac-DS name, with the final determination remaining subject to the investigation’s outcome.
- If it is manufactured under a name which belongs to another drug; or
- If it is an imitation of, or is 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
- If the label or 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
- If it has been substituted wholly or in part by another drug or substance; or
- 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 | Lactic Acid Bacillus Tablets (120 M) (Brand Name: Sporlac-DS) | BDS25003 | Manufacturing Date: Feb-2025Expiry Date: Jan-2027 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | CDL, Kolkata | SEP-2026 | NSQ Remark: The product is purported to be spurious. However, the same is subject to outcome of investigation.Firm 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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