Azithromycin, Ofloxacin Combos Among 3 Drug Batches Flagged as Purportedly Spurious by CDSCO
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued an alert concerning three additional drug batches, with preliminary findings suggesting that the products may be spurious, pending the outcome of ongoing investigations.
The batches under scrutiny include Azithromycin USP/EP/IP, Trypsin-Chymotrypsin Tablets, and Ofloxacin and Ornidazole Tablets IP.
According to official records, all three products carry the remark: “The product is purported to be spurious, however, the same is subject to outcome of investigation.”
Regulatory sources indicated that the manufacturers listed on the labels are currently under investigation.
In their responses, the firms named on the product labels denied the authenticity of the batches under scrutiny.
The actual importer, as per the label claim for the Azithromycin batch, stated that the impugned batch had not been supplied by them and described it as a spurious drug. Similarly, the actual manufacturers, as per the label claims for the trypsin-chymotrypsin and ofloxacin-ornidazole batches, clarified that the cited batches had not been manufactured by them and identified 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 | Azithromycin USP/EP/IP | 129-250324-1 | Manufacturing Date: Mar-2025Expiry Date: Mar-2029 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | CDTL, Mumbai | JAN-2026 | NSQ Remark: The product is purported to be spurious, however, the same is subject to outcome of investigationFirm Reply: The actual importer (as per label claim) has informed that the impugned batch of the product has not supplied by them and that it is a spurious drug. |
| 2 | Trypsin-Chymotrypsin Tablets | 2KU6L050 | Manufacturing Date: Dec-2024Expiry Date: Nov-2027 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | CDL, Kolkata | JAN-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 | Ofloxacin And Ornidazole Tablets IP | E-50032 | Manufacturing Date: Jan-2025Expiry Date: Dec-2028 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | State Lab | West Bengal | JAN-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. |
