CDSCO declares 4 formulations as spurious including PAN D, SHELCAL 500
New Delhi: The Central Drug Standard Control Organisation (CDSCO) has issued a list of drugs, medical devices, vaccines, and cosmetics for the month of September 2024, wherein, the apex drug regulatory body has declared 4 formulations as spurious.
The list includes Tamsulosin and Dutasteride Tablets (Urimax- D), Calcium and Vitamin D3 Tablets I.P (SHELCAL 500), Pantoprazole Gastro-Resistant and Domperidone Prolonged- Release Capsules I.P. (PAN-D), Nandrolone Decanoate Injection IP 25mg/ml (Deca- Durabolin 25 Inj.).
The actual manufacturers (as per label claim) have claimed 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.
As part of the continuous regulatory surveillance, drugs samples are picked from sales/distribution point, analyzed and list of spurious drugs are displayed on CDSCO portal on monthly basis. The purpose of displaying the spurious drugs list is to make stakeholders aware about the spurious drug batches identified in the market.
Also Read: CDSCO declares 5 formulations as spurious: Details
List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Spurious for the Month of September – 2024
S.No | Name of Drugs/medical device/cosmetics | Batch No. | Date of Manufacture | Date of Expiry | Manufactured By | Reason for failure | Drawn By | Firm reply |
1. | Tamsulosin and Dutasteride Tablets (Urimax- D) | GH30334 | May-23 | Apr-25 | Under Investigation | Description, Identification and Assay | Drugs Inspector, Odisha | 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. |
2. | Calcium and Vitamin D3 Tablets I.P (SHELCAL 500) | GDXD0581 | Aug/202 3 | July/202 5 | Under Investigation | Identification, Dissolution, Assay and Description. | Drugs Inspector, EZ, Kolkata | 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. |
3. | Pantoprazole Gastro-Resistant and Domperidone Prolonged- Release Capsules I.P. (PAN-D) | 23443507 | Sep-2023 | Aug- 2025 | Under Investigation | Assay of both Pantoprazole and Domeperidone | 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. |
4. | Nandrolone Decanoate Injection IP 25mg/ml (Deca- Durabolin 25 Inj.) | G202620 | 10/2022 | 09/2026 | Under Investigation | Identification | Drugs Inspector, NZ, Ghaziabad | 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. |
For more details, check out the full story on the link mentioned below:
https://medicaldialogues.in/pdf_upload/list-of-spurious-drugs-for-the-month-of-sept-2024-258538.pdf
