CDSCO Flags Buprenorphine Injection Batch as Purportedly Spurious, Probe Underway
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has flagged a batch of Buprenorphine Injection I.P. 2 ml as purportedly spurious, with the finding remaining subject to the outcome of an ongoing investigation.
According to the CDSCO regulatory alert, the product bears Batch No. LM1888, with a manufacturing date of April 2023 and an expiry date of May 2029. The batch was reported in July 2026 by CDL, Kolkata, under the CDSCO laboratory reporting system.
The manufacturer details for the product have been listed as “Under Investigation.” The regulatory record states that the product is purported to be spurious, while clarifying that the finding is subject to the outcome of the investigation.
In its response, the actual manufacturer mentioned on the product’s label has denied manufacturing the impugned batch. The firm has informed the authorities that the batch was not manufactured by them and has stated that the product 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
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 | Buprenorphine Injection I.P. 2ml | LM1888 | Manufacturing Date: Apr-2023Expiry Date: May-2029 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | CDL, Kolkata | JUL-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. |
Also Read:CDSCO Flags Ursodeoxycholic Acid Tablets Batch as Purportedly Spurious
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