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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Indian drug regulator CDSCO (Central Drugs Standards Control Organisation) has published the Not of Standard Quality (NSQ) drugs list for March 2025. CDSCO has published two lists – one for the NSQ Alerts reported by the Central / CDSCO laboratories (with 70 NSQ drugs) and other for NSQ Alerts reported by the State Laboratories (61 NSQ drugs).
The NSQ alert by Central laboratories report maximum failures for the acidity and heartburn drug Pantoprazole with five NSQ alerts and Calcium + Vitamin D3 formulations with eight NSQ alerts. Most frequent failures were reported for parameter Assay or Content (more than 30 failures), followed by parameters like Dissolution (21), Description (15) and Particulate matter (12). Of particular concern is the six instances of Sterility failure reported for injection products. Other parameters for which failures were reported include Clarity of solution, Related substances and pH. Drug manufacturers Gidsha Pharmaceuticals (8), Martin and Brown Bio‑sciences Pvt. Ltd.(4) and Affy Parenterals (4) tops the list for NSQ alerts. Martin & Brown was flagged in February 2025 also for high number of NSQ alerts. 46 instances of NSQ alerts were reported by CDL Kolkata and 11 by RDTL Guwahati while CDTL, Mumbai reported 9 instances and RDTL Chandigarh 4.
In the NSQ alert by State laboratories Albendazole Tablets 400mg (9 instances), Paracetamol tablets 500 mg top the list. Maximum failures were reported for parameter Dissolution (21 instances), followed by Assay (7), Description (4), Misbranding of the drug (3). Eleven instances of failure of different cosmetics like Lipstick, Beatu creams, Bleach, Facewash etc for presence of Mercury is of serious concern. M/s. Samkem, Indore (MP) reported 8 failures, followed by Kerala Medical Services Corporation Limited (4 failures). Drugs Testing Laboratory, Thiruvananthapuram reported 28 failures, while state drug testing laboratory at Telangana 18. Other laboratories who reported failures include state laboratories of West Bengal, Jammu & Kashmir (J&K), Himachal Pradesh.
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. Drugs that fail to meet the quality standards or specifications are termed Not of Standard Quality (NSQ) drugs.
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