CDSCO Flags Popular Pantoprazole, Telmisartan Batches as Spurious in November Alert

The flagged products include Pantoprazole Gastro-resistant Tablets IP (PAN 40), a commonly prescribed anti-ulcer medication, and Telmisartan Tablets IP 40 mg (Telma 40), a frontline antihypertensive drug. Both products were tested at a CDSCO laboratory in Chandigarh and were reported in November 2025.

According to official records, the batches failed authenticity verification. CDSCO noted that “the product is purported to be spurious; however, the same is subject to the outcome of investigation.”

Significantly, the actual manufacturer, whose names appeared on the product labels, have informed authorities that the impugned batches were never manufactured by them, strongly indicating that the drugs are spurious in nature.

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.