Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Indian drug regulator CDSCO has published the Not of Standard Quality (NSQ) alert lists for May 2025. A total of 58 drugs were declared NSQ by CDSCO’s Central Laboratories, while State Laboratories reported an additional 128 NSQ cases during the same month.
As part of ongoing regulatory surveillance, Central and State drug control authorities collect samples from sales and distribution points. These samples are analyzed for compliance, and NSQ findings are subsequently published on the CDSCO portal.
NSQ Alerts – CDSCO/Central Laboratories
The most frequent quality failures reported by Central Laboratories included:
Manufacturers with the highest number of NSQ citations from Central Labs included:
Products frequently flagged included Calcium Carbonate + Vitamin D3 Tablets IP (CALXIA‑500), Pantoprazole for Injection BP 40 mg, and Telmisartan Tablets IP 40 mg. The labs involved in identifying these cases included CDL Kolkata, and RDTLs in Guwahati, Chandigarh, Mumbai, Indore, and Chennai.
NSQ Alerts – State Laboratories
From the State Laboratory list, firms with multiple NSQ drugs included:
Top failure reasons reported by State Laboratories were:
The most frequently cited drug categories included Albendazole Tablets IP 400 mg, Amoxycillin & Potassium Clavulanate formulations (Tablets, capsules and syrups), and Aceclofenac + Paracetamol Tablets. State laboratories from Punjab, Karnataka, Maharashtra, Telangana, Himachal Pradesh, and Tripura reported the highest number of NSQ alerts.
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