CDSCO Flags PAN-40, AUGMENTIN Batches as Spurious in November 2024 Alert

This comes as a part of CDSCO’s continuous regulatory surveillance program, where samples are collected from sales and distribution points for thorough analysis. The results of these investigations are then shared on the CDSCO portal to keep stakeholders informed about counterfeit or spurious batches identified in the market.

By doing so, the CDSCO aims to enhance public awareness and support efforts to safeguard public health by ensuring only authentic products are distributed.

Recently, the apex drug regulatory body release the list of spurious drugs for the month of November, 2024. Among the flagged items is a batch of Pantoprazole Gastro-Resistant Tablets I.P. (commonly known as PAN-40), which failed critical quality tests. Manufactured in August 2023 with an expiry date of January 2026, this product exhibited deficiencies in dissolution and assay tests. The labeled manufacturer has categorically denied producing this batch, indicating it as a counterfeit drug. The matter remains under investigation to confirm its authenticity and origin.

Additionally, a batch of Amoxycillin and Potassium Clavulanate Tablets I.P. (marketed as AUGMENTIN 625 DUO), has also been flagged as it failed identification and assay tests. This batch, manufactured in February 2024 and set to expire in July 2025, was also disclaimed by the labeled manufacturer. Similar to the case of PAN-40, the product is suspected to be counterfeit, and authorities are continuing their investigation.

List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Spurious for the Month of November– 2024

S.No.	Name of Drugs/medical device/cosmetics	Batch No.	Date of Manufact ure	Date of Expiry	Manufactured By	Reason for failure	Drawn By	Firm’s reply	Remarks
1.	Pantoprazole Gastro-Resistant Tablets I.P. ( PAN-40)	23443074	Aug-2023	Jan-2026	Under Investigation	Dissolution (Acid Stage) and Assay	Drugs Inspector, Bihar	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 product is purported to be spurious, however, the same is subject to outcome of investigation.
2.	Amoxycillin and Potassium Clavulanate Tablets IP (AUGMENTIN 625 DUO)	824D054	Feb-2024	Jul-2025	Under Investigation	Identification and Assay	Drugs Inspector, Ghaziabad	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 product is purported to be spurious, however, the same is subject to outcome of investigation.

Under Section 17-B of the Drugs and Cosmetics Act, 1940, a drug is deemed to be spurious if it violates specific criteria established to ensure authenticity and quality. A drug is considered spurious if it is manufactured under a name that belongs to another drug or if it is an imitation or substitute that resembles another drug in a way likely to deceive consumers. Additionally, if the drug’s label or container carries the name of another drug without clearly revealing its true nature, it also falls into the spurious category.

The act further states that a drug is spurious if its label or container lists the name of an individual or company purported to be its manufacturer, but that individual or company is fictitious or non-existent. Moreover, drugs that have been wholly or partially substituted with another substance or those falsely claiming to be a product of a specific manufacturer without actually being so are also classified as spurious.