CDSCO Flags Nandrolone Injection as 'Possibly Spurious' After Bihar Testing, Batch Under Investigation
Investigation
New Delhi: In its latest drug alert for April 2025, the Central Drugs Standard Control Organization (CDSCO) has flagged a batch of Nandrolone Decanoate Injection I.P. 50 mg/ml (DECA-DURABOLIN 50 Inj.) as purportedly spurious, after the sample failed quality checks during routine surveillance.
The flagged batch, number G303123, manufactured in November 2023 with an expiry date of October 2027, was tested by drug inspectors in Bihar. The sample failed the tests for identification and assay of Nandrolone Decanoate.
According to the CDSCO report, the company listed on the label informed authorities that it did not manufacture the impugned batch, indicating that the drug in question is spurious.
"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," the CDSCO noted.
The CDSCO further added that the product is “purported to be spurious”, pending the outcome of further investigation.
List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Spurious for the Month of April-2025
S.No. | Name of Drugs/medical device/cosmetics | Batch No. | Date of Manufactu re | Date of Expiry | Manufactured By | Reason for failure | Drawn By | Firm’s reply | Remarks |
1. | Nandrolone Decanoate Injection IP 50 mg/ml (DECA- DURABOLIN 50 Inj.) | G303123 | Nov-2023 | Oct-2027 | Under Investigation | Identification and Assay of Nandrolone Decanoate | Drugs Inspector, Bihar | 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. | The product is purported to be spurious, however, the same is subject to outcome of investigation. |
This alert forms part of CDSCO’s ongoing monthly surveillance, under which drug samples are randomly collected from points of sale and distribution and tested for quality compliance. The results, including lists of spurious, adulterated, or misbranded drugs, are made publicly available to alert stakeholders and safeguard public health.
Spurious Drugs: A drug shall be deemed to be spurious;
- If it is manufactured under a name which belongs to another drug; or
- if it is an imitation of, or is 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
- If the label or 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
- If it has been substituted wholly or in part by another drug or substance; or
- 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)
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