Batch of Telma AM earlier classified as NSQ now flagged as Spurious
New Delhi: Through a recent revised Drug Alert for January 2025, the Central Drugs Standard Control Organisation (CDSCO) has classified a batch of TELMA AM as Spurious. The batch was earlier classified as Not of Standard Quality (NSQ).
Medical Dialogues team had reported that 93 drug formulations were declared as Not of Standard Quality (NSQ) in January 2025, based on testing conducted by various State Drug Control Authorities. Among these was a batch of TELMA AM (Batch No. 5240367), listed under Glenmark Pharmaceuticals Ltd., Solan (H.P.), which was flagged by the State Drugs Testing Laboratory, Kolkata for “not conforming to I.P. standards.”
Also Read: 93 Formulations Declared Not of Standard Quality as per Data Provided by States: CDSCO Drug Alert
However, the same batch has now also been classified as “purportedly spurious” in CDSCO’s revised alert, with Glenmark informing that it did not manufacture this batch.
The batch in question — Batch No. 5240367, with a manufacturing date of March 2024 and expiry of February 2027 — carries Glenmark’s name on the label. However, the company has officially clarified that it did not manufacture this particular batch.
“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 CDSCO stated in its revised alert.
The matter is now under active investigation. While the product is currently listed as “purportedly spurious,” the final classification will depend on the outcome of the ongoing inquiry.
Drug Alert for the Month of January–2025 (Revised)
List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of January– 2025 (Revised)
S. No | Name of Drugs/medical device/cosmetics | Batch No. | Date of Manufacture | Date of Expiry | Manufactured by | Reason for failure | Drawn By | Firm’s reply | Remarks |
79. | TELMA AM | 5240367 | Mar-24 | Feb-27 | Under Investigation | Does not confirm to I.P. | - | 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 |
