CDSCO Flags 5 Batches of Widely Used Drugs Including Azithral-500, Telma-AM as Potentially Spurious
New Delhi: The Central Drugs Standard Control Organization (CDSCO) has flagged five widely used medicines, including Azithral-500, Telma-AM, Noophin, Chymoral Forte, after samples tested in state and CDSCO laboratories were reported as purportedly spurious.
The affected medicines are Azithromycin I.P. 500 mg Tablets (Azithral-500), Telmisartan + Amlodipine Tablets IP (Telma-AM), Buprenorphine Injection (Noophin), and two batches of Trypsin-Chymotrypsin Tablets (Chymoral Forte)—all major brands commonly prescribed across India for bacterial infections, hypertension, pain relief, and inflammation.
As per CDSCO reports from October 2025, the manufacturers listed on the product labels are “under investigation.” In each case, the actual companies whose names appeared on the labels have denied manufacturing these batches, prompting concerns over the circulation of counterfeit medicines in the market.
Under the Drugs and Cosmetics Act, 1940, a drug is considered spurious if it:
(a) if it is imported under a name that 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
The term “Spurious Drug” has been defined under Section 17-B of the Drugs and Cosmetics Act, 1940
S.No | Name of Product | Batch No | Manufacturing Dates | Manufacturer Details | Reporting Source | Reporting by Lab/State | Reporting Month & Year | Remarks |
1 | Azithromycin I.P 500 mg Tablets (Azithral-500) | 2408000201 | Manufacturing Date: Mar-2024Expiry Date: Feb-2026 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | State Lab | BDCL, PATNA | OCT-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 | Telmisartan 40 mg and Amlodipine 5 mg Tablets IP (Telma-AM) | 05241217A | Manufacturing Date: Aug-2024Expiry Date: Jul-2027 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | State lab | NCT of Delhi | OCT-2025 | NSQ Remark: The product is purported to be spurious, however, the same is subject to outcome of investigation.Firm 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 | BUPRENORPHINE INJECTION - 2ml ((NOOPHIN) | LM 18907 | Manufacturing Date: Jul-2023Expiry Date: Jun-2029 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | CDL, Kolkata | OCT-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 | Trypsin-Chymotrypsin Tablets (Chymoral Forte) | 2KU6L057 | Manufacturing Date: Dec-2024Expiry Date: Nov-2027 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | CDL, Kolkata | OCT-2025 | NSQ Remark: The product is purported to be spurious, however, the same is subject to outcome of investigation.Firm 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 | Trypsin-Chymotrypsin Tablets (CHYMORAL FORTE) | 2KU6L030 | Manufacturing Date: Jul-2027Expiry Date: Jun-2027 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | CDL, Kolkata | OCT-2025 | NSQ Remark: The product is purported to be spurious, however, the same is subject to outcome of investigation.Firm 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. |
