CDSCO Probes Two Suspected Spurious Antibiotic Batches of Cefixime, Amoxycillin-Clavulanate
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued an alert regarding Cefixime Dispersible Tablets IP and Amoxycillin and Potassium Clavulanate Tablets IP after preliminary findings indicated that the two batches may be spurious, subject to the outcome of an ongoing investigation.
The suspected products were included in the May 2026 drug alert issued by CDSCO following reports received from the Central Drugs Laboratory (CDL), Kolkata under CDSCO Labs.
he products under scrutiny are Cefixime Dispersible Tablets IP bearing batch number TC2439 and Amoxycillin and Potassium Clavulanate Tablets IP bearing batch number 825D167.
The batch of Cefixime Dispersible Tablets IP was manufactured in October 2024 with an expiry date of March 2027, while the batch of Amoxycillin and Potassium Clavulanate Tablets IP was manufactured in June 2025 and carries an expiry date of November 2026.
Both products were reported by the Central Drugs Laboratory (CDL), Kolkata, under CDSCO Labs in the May 2026 drug alert. Regulatory records list the manufacturer details as "Under Investigation."
The official remarks in the CDSCO report state, "The product is purported to be spurious, however, the same is subject to outcome of investigation."
According to the firms' responses, the actual manufacturers named on the respective product labels have informed the authorities that the impugned batches were not manufactured by them and have identified the products as spurious drugs.
CDSCO has initiated further investigation to determine the source, authenticity and distribution channel of the suspected counterfeit batches.
Under Section 17-B of the Drugs and Cosmetics Act, 1940, a drug shall be deemed to be spurious—
(a) if it is imported under a name which belongs to another drug;
(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;
(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;
(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, and the ongoing investigation will determine whether the two batches meet the legal criteria for being declared spurious.
| S.No | Name of Product | Batch No | Manufacturing Dates | Manufacturer Details | Reporting Source | Reporting by Lab/State | Reporting Month & Year | Remarks |
|---|---|---|---|---|---|---|---|---|
| 1 | Cefixime Dispersible Tablets IP | TC2439 | Manufacturing Date: Oct-2024Expiry Date: Mar-2027 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | CDL, Kolkata | MAY-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. |
| 2 | Amoxycillin and Potassium Clavulanate Tablets IP | 825D167 | Manufacturing Date: Jun-2025Expiry Date: Nov-2026 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | CDL, Kolkata | MAY-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. |
