Suspected Spurious Buprenorphine Injection Batch Under Scanner, CDSCO Launches Investigation
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued an alert regarding an additional drug batch, with preliminary findings indicating that Buprenorphine Injection IP 2 ml (Batch No. LM1889), manufactured in December 2023 and expiring in November 2029, may be spurious, subject to the outcome of an ongoing investigation.
The batch under scrutiny is Buprenorphine Injection IP 2 ml, bearing batch number LM1889, with a manufacturing date of December 2023 and expiry date of November 2029.
According to official records, the product carries the remark: “The product is purported to be spurious, however, the same is subject to outcome of investigation.”
Regulatory sources have indicated that the manufacturer mentioned on the label is currently under investigation, with details of the firm yet to be confirmed.
In response, the actual manufacturer, as per the label claim, has denied any association with the batch. The firm clarified that the impugned batch was not manufactured by them and identified the product as a spurious drug.
In accordance with the Drugs and Cosmetics 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 IP 2ml | LM1889 | Manufacturing Date: Dec-2023Expiry Date: Nov-2029 | Manufacturer Name: Under InvestigationManufactured By: Under Investigation | CDSCO Labs | CDL, Kolkata | MAR-2026 | 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. |
