Batch of Tofajak Tablets earlier classified as NSQ now flagged as Spurious
New Delhi: Through a recent revised drug alert, the Central Drugs Standard Control Organization (CDSCO) has classified a batch of Tofacitinib Tablets IP 5 mg (TOFAJAK TABLETS) as spurious. The batch was earlier classified as Not of Standard Quality (NSQ).
The Medical Dialogues team had reported that 41 drug formulations were declared as Not of Standard Quality (NSQ) in November 2024, based on testing conducted by various CDSCO laboratories. Among these was a batch of Tofacitinib Tablets IP 5 mg (TOFAJAK TABLETS) (Batch No. 4F30009), listed under Cipla LTD , which was flagged by the Regional Drugs Testing Laboratory (RDTL) Chandigarh for failing identification and assay of Tofacitinib citrate calculated as Tofacitinib.
However, the same batch has now also been classified as “purportedly spurious” in CDSCO’s revised alert, with Cipla informing that it did not manufacture this batch.
The batch in question — Batch No. 4F30009, with a manufacturing date of May 2024 and expiry of April 2026 — carries Cipla’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 November–2024 (Revised)
List of Drugs, Medical Devices, Vaccines and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of November–2024 (Revised)
S. No | Name of Drugs/medical device/cosmetics | Batch No. | Date of Manufacture | Date of Expiry | Manufactured by | Reason for failure | Drawn By | Firms’s reply | Remarks |
40. | Tofacitinib Tablets IP 5 mg (TOFAJAK TABLETS) | 4F30009 | 05/2024 | 04/2026 | Under Investigation | Identification and Assay of Tofacitinib citrate calculated as Tofacitinib | Drugs Control Officer, Gurugram | 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. |
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