CDSCO Flags 7 Batches of Popular Medicines as Purportedly Spurious in December
New Delhi: In a disclosure that raises serious concerns over drug authenticity and patient safety, the Central Drugs Standard Control Organisation (CDSCO) has flagged seven batches of commonly prescribed medicines as purportedly spurious following quality surveillance and authenticity checks conducted at central and state drug testing laboratories.
According to official data for December 2025, the medicines flagged as purportedly spurious include Chymoral Forte (Trypsin–Chymotrypsin Tablets) from batch numbers 2KU6L012 and 2KU6L045; Montina-L Tablets, containing Montelukast Sodium and Levocetirizine Hydrochloride (batch SPJ241236); Telma-AM, a combination of Telmisartan 40 mg and Amlodipine 5 mg Tablets (batch numbers 05241038A and 18240626); Telma 40 (Telmisartan Tablets IP 40 mg) from batch 18240413; and Pantop-D SR, comprising Pantoprazole Sodium gastro-resistant and Domperidone prolonged-release capsules (batch SPA250021).
All the above batches were reported by CDSCO laboratories and state drug testing laboratories, including RDTL Chandigarh, Food & Drugs Laboratory, Vadodara, and FDAL Mumbai, during routine testing and surveillance.
According to CDSCO, “The product is purported to be spurious; however, the same is subject to the outcome of the investigation.”
In line with the official firm replies recorded in the CDSCO data, the manufacturers informed regulators that the impugned batch of the product has not been manufactured by them and that it is a spurious drug.
In accordance with the Drug and Cosmetic Act, a drug shall be deemed to be spurious—
(a) if it is imported under a name which belongs to another drug; or
(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; or
(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; or
(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
Medicines Flagged as Spurious
| S.No | Name of Product | Batch No | Manufacturing Dates | Manufacturer Details | Reporting Source | Reporting by Lab/State | Reporting Month & Year | Remarks |
|---|---|---|---|---|---|---|---|---|
| 1 | (CHYMORAL FORTE) Trypsin-Chymotrypsin Tablets | 2KU6L012 | Manufacturing Date: Feb-2024Expiry Date: Jan-2027 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | State lab | Food & Drugs Laboratory, Vadodara | DEC-2025 | 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. |
| 2 | (Montina-L Tablets) Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP | SPJ241236 | Manufacturing Date: Sep-2024Expiry Date: Aug-2026 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | RDTL,Chandigarh | DEC-2025 | 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. |
| 3 | Telma-AM Telmisartan 40 mg and Amlodipine 5 mg Tablets IP | 05241038A | Manufacturing Date: Jul-2024Expiry Date: Jun-2027 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | RDTL, Chandigarh | DEC-2025 | 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. |
| 4 | Telma 40 Telmisartan Tablets I.P. 40 mg | 18240413 | Manufacturing Date: May-2024Expiry Date: Apr-2027 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | RDTL, Chandigarh | DEC-2025 | 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. |
| 5 | Telma-AM Telmisartan 40mg and Amlodipine 5 mg Tablets IP | 18240626 | Manufacturing Date: Aug-2024Expiry Date: Jul-2027 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | State Lab | FDAL, Mumbai | DEC-2025 | 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. |
| 6 | Chymoral Forte Trypsin-Chymotrypsin Tablets | 2KU6L045 | Manufacturing Date: Dec-2024Expiry Date: Nov-2027 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | State Lab | FDAL, Mumbai | DEC-2025 | 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. |
| 7 | (Pantop-D SR) Pantoprazole Sodium Gastro-resistant and Domperidone Prolonged -release Capsules IP | SPA250021 | Manufacturing Date: Jan-2025Expiry Date: Dec-2026 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | RDTL,Chandigarh | DEC-2025 | 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. |
