Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
CDSCO has published the NSQ (Not of Standard Quality) alert for July 2024. The list published by CDSCO on 22 Aug 2024, lists fifty seven drug products and include common drugs like Paracetamol, Ofloxacin, Azithromycin, Aspirin, Pantoprazole, Diclofenac. More than twenty products in the list failed for test for Dissolution and sixteen products failed for Assay. Other reason for failure include Description and Particulate matter, Sterility and Bacterial endotoxins (BET).
The list also figures drugs by pharma biggies like Cipla (Budesonide Nebuliser Suspension for Assay; Tamsulosin and Dutasteride Tablets for Assay) Aurobindo (Amoxycillin and Potassium Clavulanate for Description); Hetero Labs (Carboplatin for Identification and Description),
Majority of the NSQ drugs are tablets and capsules (37) and followed by sterile injectables (11). The drugs were tested at by central laboratories like the Central Drugs Laboratory, Kolkata; CDTL -Mumbai; CDTL, Hyderabad; RDTL, Guwahati; RDTL, Chandigarh.
CDSCO also published a NSQ list of thirteen drugs tested by state laboratories. The drug products were tested by Drugs Testing Laboratory Thiruvananthapuram and CFDL Jammu (J&K)
Leave a Comment
You must be logged in to post a comment.