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  • CDSCO Flags PAN-40,...

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

Farhat NasimWritten by Farhat Nasim Published On 2025-01-01T14:22:34+05:30  |  Updated On 1 Jan 2025 2:22 PM IST
Batch of Telma AM earlier classified as NSQ now flagged as Spurious
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New Delhi: The Central Drugs Standard Control Organization (CDSCO) has declared certain batches of Pantoprazole Gastro-Resistant Tablets I.P. (PAN-40) and Amoxycillin and Potassium Clavulanate Tablets I.P. (AUGMENTIN 625 DUO) as spurious for the month of November 2024.

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.

cdscospurious drugspan-40augmentin 625 duonovember 2024drug safetyspurious pharmaceuticalsfake drugsdrugs and cosmetics actcounterfeit drugsdrug investigationcdsco portalpharmalatest pharma newspharma newsdrug alert
Farhat Nasim
Farhat Nasim

    Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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