Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
The Indian drug regulator, CDSCO, has published a list of spurious drugs detected in November 2024. During regulatory surveillance, drug inspectors in Bihar identified spurious samples of the popular acidity medicine Pan 40 (Pantoprazole by Alkem). Similarly, drug inspectors in Ghaziabad found spurious samples of the widely used antibiotic Augmentin 625 Duo (Amoxicillin + Clavulanic Acid by GSK). Both Alkem and GSK have informed CDSCO that the impugned batches of these products were not manufactured by them and the drugs are spurious. CDSCO is currently investigating these cases.
According to a CDSCO notification, spurious drug products are drug formulations designed to resemble popular branded drugs, intending to deceive buyers and capitalize on the original product’s reputation. The manufacture and distribution of spurious drugs are serious offenses, carrying severe penalties including imprisonment for not less than 10 years and a fine of at least ten lakh rupees.
CDSCO also published a list of Non-Standard Quality (NSQ) drugs detected in November 2024. As part of regulatory surveillance, drug inspectors from the Central (CDSCO) and State Licensing Authorities (SLAs) collect drug samples from sales and distribution points, which are then analyzed in central or state laboratories. CDSCO identified 41 drugs that were tested in central laboratories and found to be of non-standard quality or not meeting specifications. Additionally, CDSCO listed 70 drugs collected and tested by state drug inspectors, which also did not meet quality standards. These drugs failed due to various parameters such as assay, dissolution, sterility, particulate matter, content uniformity, impurities, labeling issues and others.
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