CDSCO Flags Telma AM Batch as Purportedly Spurious, Manufacturer Denies Making It
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has listed a batch of Telmisartan 40 mg and Amlodipine 5 mg Tablets IP, sold as TELMA AM, as purportedly spurious in its August 2026 alert. The finding is subject to the outcome of an investigation.
The entry identifies the batch as 18230791, manufactured in December 2023 with an expiry date of November 2026. The sample was reported by the Drug Testing Laboratory (DTL), Delhi, under the State Lab reporting category.
According to the alert, the manufacturer named on the label informed authorities that it had not manufactured the batch and described it as spurious. The manufacturer details in the alert remain listed as “Under Investigation.”
CDSCO’s alert states that the product is purported to be spurious, subject to the investigation’s outcome. Section 17-B of the Drugs and Cosmetics Act, 1940, includes within its definition of a spurious drug one that falsely purports to be the product of a manufacturer.
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
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 | Telmisartan 40 mg and Amlodipine 5mg tablets IP (TELMA AM) | 18230791 | Manufacturing Date: Dec-2023 Expiry Date: Nov-2026 | Manufacturer Name: Under Investigation Manufactured By: Under Investigation | State Lab | DTL, Delhi | AUG-2026 | 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. |
