The Central Drugs Standard Control Organisation (CDSCO) has published the Revised List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/ Spurious/ Adulterated/ Misbranded for December, 2023 This list is dated 21st February, 2024.
This list includes one drug Pantoprazole Gastro-resistant Tablets IP (PAN40) which is manufactured by ALKEM HEALTH SCIENCE, Unit-2, Samardung, Karek Block, PO- Namthang, South Sikkim,737137. However, 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. Thus, the product is purported to be spurious, however, the same is subject to the outcome of further investigation.
The batch other details of the drug in question are as follows:
- Batch No.: 22442076
- Date of Manufacture: 07/2022
- Date of Expiry: 12/2024
- Reason for failure: Assay of Pantoprazole Gastro-resistant Tablets IP (PAN40)
- Drawn By and From: Drugs Control Department Assam, RDTL Guwahati
