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New Delhi: The Central Drugs Standard Control Organization (CDSCO) has identified 94 batches of medicines and medical products as "Not of Standard Quality" (NSQ) after samples tested in September 2025 by its central and state laboratories failed to meet required pharmacopeial and safety standards.The flagged products cover a wide range of therapeutic categories, including antibiotics, analgesics, antipyretics, antidiabetics, and other essential medicines.These include Glimepiride Tablets IP 1 mg, manufactured by Karnataka Antibiotics and Pharmaceuticals, Telmisartan tab I.P. 40 mg, manufactured by Helax Healthcare, Bromhexine Hydrochloride Tablets IP 4 mg, manufactured by J.P. Industries, Rabeprazole Sodium Injection IP, manufactured by Martin & Brown Bio-Sciences, Dexamethasone Injection I.P., manufactured by SGS Pharmaceuticals, Pantoprazole Tablets I.P,. manufactured by Healers Lab, Cefixime Tablets IP 200 mg, manufactured by SVR Healthcare, and others.Also Read: Spurious Drugs Alert: Diazepam, PAN 40, and PAN-D Capsules Under InvestigationThe list further includes Diclofenac Sodium and Paracetamol Tablets IP manufactured by Zydus Healthcare, Clobetasol Propionate Neomycin Sulfate and Miconazole Nitrate Cream manufactured by Macleods Pharmaceuticals, Ivabradine Tablets 5 mg manufactured by Hetero Labs.This came as part of the continuous regulatory surveillance, where drug samples are picked from sales/distribution points, analyzed, and lists of Not of Standard Quality (NSQ) drugs are displayed on the CDSCO portal on a monthly basis.The reasons for failure varied across samples — the most frequent being assay failure (active ingredient content outside permissible limits), dissolution issues, pH deviations, and sterility test failures in parenteral preparations. A few samples were also flagged for visual defects and labeling discrepancies, marking regulatory non-conformance.The CDSCO report also noted that several states and Union Territories did not furnish any data for the Not of Standard Quality (NSQ) Drug Alert for the month of September 2025. The states and UTs that remain pending in submission include Andaman and Nicobar Islands, Arunachal Pradesh, Assam, Bihar, Chandigarh, Chhattisgarh, Dadra and Nagar Haveli, Daman and Diu, Delhi, Goa, Jammu and Kashmir, Jharkhand, Kerala, Ladakh, Lakshadweep, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Puducherry, Tamil Nadu, and Tripura.Drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs. The term ‘standards of quality’ is defined under Section 16 (1) (a) of the Drugs and Cosmetics Act, 1940, as ‘standards of quality’, meaning that the drug complies with the standards set out in the Second Schedule of the said Act.NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF SEPTEMBER 2025S.NoName of ProductBatch NoManufacturing DateExpiry DateManufactured ByNSQ ResultReporting SourceReporting by Lab/StateReporting Month & Year1Glimepiride Tablets IP 1 mg12800524Mar-2024Feb-2026Karnataka Antibiotics And Pharmaceuticals Ltd Plot No.14, II Phase,Peenya,Bengaluru-560058sample does not conform to I.P with respect to the test for Related substances.CDSCO LabsCDTL, IndoreSEP-20252SPADE SERRATIOPEPTIDASE TABLETS IP 5 mgISP122May-2025Apr-2027Med Manor Organics Pvt.Ltd. Unit-II, Kh. No.143M/7 Village-Raipur Pagwana Bhagwanpur, Tehsil-Roorkee, Distt.Haridwar, Uttarakhand-247661.sample received does not conform to the I.P. 2022 standard with respect to Assay of SerratiopeptidaseCDSCO LabsCDTL, MumbaiSEP-20253MECOSOL-Plus Capsules Mehtylcobalamin, Alpha Lipoic acid, Folic Acid, Pyridoxine HCl & Thiamine Mononitrate CapsulesVGC240264BJul-2024Jun-2026Vrindavan Global Plot No. 23-B &C, Ind. Area Lodhimajra, Baddi, Distt. Solan (H.P.) 173205sample does not conforms to Manufacturers specification with respect to the Tests for Disintegration ,Uniformity of weight and Assay of Alpha Lipoic Acid and Folic acid.CDSCO LabsCDTL, MumbaiSEP-20254Albendazole Tablets IPPGT25451Jun-2025May-2028Affy Parenterals (WHO- cGMP/ISO 9001:2015 Certified Co.) Vill. Gullerwala, P.O. Baddi, Distt. Solan- 173 205 (HP)DissolutionState LabSDTL Raipur ChhattisgarhSEP-20255Diclofenac Sodium and Paracetamol Tablets IPI405175Oct-2024Sep-2026Zydus Healthcare Ltd.,(Unit II) 967 (P), 968 (P), 970 (P), Duga Circle, Kamarey Bhasmay, Kumrek, Sikkim-737132Assay & DissolutionState LabGovernment of NCT of DelhiSEP-20256Tamoxifen Tablets IPSPOT250033Mar-2025Feb-2027Salus Pharmaceuticals 480/211, Harraipur, PO Gurumajra,Teh Baddi, Distt.Solan (H.P.) 173205Test for DissolutionState LabGovernment of NCT of DelhiSEP-20257Amoxycillin & Potassium Clavulana Tablet I.PMFK0722Sep-2024Aug-2026Medicef Pharma, Plot No. 28, 29 & 48, Phase-I, EPIP, Jharmajri, Baddi, Dist. Solan - 173205, (H.P.)Spurious.State LabSDTL, Kolkata, West Bengal.SEP-20258TELMISARTAN TAB I.P. 40 MG.GT-2502Mar-2025Feb-2027Helax Healthcare Pvt. Ltd., Khasra No. 410, Vill. Karondi, Haridwar.DescriptionState ...
