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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
The Central Drugs Standard Control Organisation (CDSCO) has published the NSQ (Not of Standard Quality) list of drugs for February 2025. The list comprises two parts—one detailing drugs identified as NSQ by Central Laboratories and the other by State Laboratories.
NSQ List from Central Laboratories:
The CDSCO NSQ list (Central Laboratories) for February includes 47 drugs. With three instances of failure, Rabeprazole Sodium tops the list. Other drugs with multiple instances of failure include Sodium Lactate Injection (4 instances) and Vitamin B Complex Syrups (5 instances). A total of 34 firms are implicated in the list. Maximum failures were reported for Martin & Brown Bio-Sciences Pvt. Ltd., Baddi (5 instances) and Apple Formulations, Roorkee (4 instances). No frontline pharmaceutical companies were named in this list.
Major reasons for failure were Assay (18 instances), Dissolution (10 instances), Description (10 instances). Other parameters for which failures were reported include pH, Sterility, Bacterial Endotoxins, Particulate Matter, Content Uniformity, and Related Substances (impurities).
The failures were reported by the Central laboratories CDTL Mumbai, CDTL Indore, CDTL Hyderabad, RDTL Guwahati, RDTL Chandigarh, and CDL Kolkata.
NSQ List from State Laboratories:
The CDSCO NSQ list (State Laboratories) highlights 56 drugs as NSQ. The major reasons for failure were again Description (15 instances), Assay (14 instances), Dissolution (10 instances). Other reported parameters include Disintegration Test, Reducing Sugar, Alcohol Content, pH, and Sterility.
A total of 36 firms were identified in the NSQ list. Modern Laboratories, Indore reported the maximum number of failures (6), followed by Signoret Pharmaceuticals, SAS Nagar and Kerala Medical Services Corporation, each with 4 failures
The State Laboratories which reported the NSQ list are from Jammu & Kashmir, Telangana, Tripura, West Bengal, Kerala, and Puducherry.
Central and State Drug authorities routinely pick samples of drug products from point of sale and distribution points and get the products tested at government laboratories as part of continuous regulatory surveillance. The NSQ lists are published by CDSCO to raise awareness among stakeholders regarding medicines that fail to meet standard quality.
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