The Central Drugs Standard Control Organisation (CDSCO) has revised the List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/ Spurious/ Adulterated/ Misbranded for May 2022. This list was published on December 20, 2023.
CDSCO has purported Omeprazole (Delayed-Release) and Domperidone (Sustained Release) Capsules as spurious. This drug is purported to be manufactured by Dr. Reddys Laboratories Ltd., Village Mauja Thana, Baddi173205, Dist. Solan, Himachal Pradesh. However, the actual manufacturer (as per label claim) has stated 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 outcome of investigation.
The batch other details of the drug in question are as follows:
- Batch No.: E2100419
- Date of Manufacture: 01/2021
- Date of Expiry: 12/2022
- Reason for failure: Assay of Omeprazole and Domperidone
- Drawn By and From: Drugs Control Department Assam, RDTL Guwahati
