New Delhi: In line with the ‘Not of Standard Quality’ data provided by states, the apex drug regulatory body, the Central Drug Standard Control Organisation (CDSCO), in its latest drug safety alert, has flagged 11 medicine batches for failing to qualify for a random sample test for August 2024.The list of drugs declared not of standard quality includes Paziva -40 manufactured by Gnosis Pharmaceuticals, Pantomed -40 manufactured by Digital Vision, Cefixime Oral Suspension IP (Dry Syrup) manufactured by Nestor Pharmaceuticals, Moxymed CV manufactured by Alexa Pharmaceuticals, Frusemide Injection manufactured by Nestor Pharmaceuticals and others.Many factors contributed to the drug samples’ failure in the test, such as non-compliance with the IP requirements for the particular drug, failure of the dissolution test, pH, and some assays of the drug test, among others.In addition to the above, the alert mentioned that the Not of Standard Quality (NSQ) data was not received as per Format and in EXCEL SHEET from State Drugs Licensing Authorities of Karnataka (PDF format), Thiruvanthapuram (Excel format), and Jammu Kashmir (Excel Format) for the Month of August 2024 as per DCG(I) Circular dated 09.02.2024. Furthermore, the alert noted that the State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Pondicherry, Telangana, Delhi, Uttarakhand, West Bengal, Andaman & Nicobar, Dadar, and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of August, 2024 as per DCG(I) Circular dated 09.02.2024.NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF AUGUST – 2024.B. State LaboratoriesS.NoProduct/Drug NameBatch No.Manufacturing DateExpiryDateManufactured ByNSQ ResultReported byCDSCO Laboratory1.Paziva -40GT30023405/2304-25M/s.GnosisPharmaceuticalsPvt.Ltd, Nahan Road , Village Moginand ,Kala-Amb Dist.Sirmour, HP- 173 030It fails the test ‘Dissolution’as per IPDrugs TestingLaboratoryThiruvananthapura m2.Pantomed -40GTEO230 C01/2412-25Digital Vision 176,Mauza ogli, NahanRoad, Kala -Amb, Dist Sirmour – 173 030It fails the test ‘Dissolution’as per IPDrugs TestingLaboratoryThiruvananthapura m3.Cefixime Oral Suspension IP (Dry Syrup)CADA-0209 /2308/25NestorPharmaceuticals Ltd, 11, Western Extension Area, Faridabad -121001It fails the test ‘Assay’ and ‘water’ asper IPDrugs TestingLaboratoryThiruvananthapura m4.Moxymed CVABT 2331611/2304/25Alexa Pharmaceuticals, Plot No. 20, ExtHPSIDC, Indl.Area, Baddi, Solan – 173 205The content of AmoxycillinandClavulanicacid is notwith in thelimits ofschedule ‘V’ of Drugs and CosmeticsAct & Rules as mentionedDrugs TestingLaboratoryThiruvananthapura min theLaboratoryprotocol5.FrusemideInjection IP 20 mgFRIB-0301/2412/25NestorPharmaceuticals Ltd, Faridabad- 121 001It fails thetest ‘Sterility’ as per IPDrugs TestingLaboratoryThiruvananthapura m6.Kudajarishtam011001/24NilBala Herbals,Industrial Estate,Edakkulangara, KollamIt fails thetests ‘TotalSolids’ and‘Specificgravity’ asper API.Drugs TestingLaboratoryThiruvananthapura m7.Tab NodosisSMST-2415102/2401/26Steadfast Medishieldpvt.Ltd, Atkhasra,No.322,Nanhera , Anantpur, Bhgwanpur, Roorkee,Dist. HaridwarIt fails the test ‘Assay’ asper IPDrugs TestingLaboratoryThiruvananthapura m8.Haridrakhanda m207/2303/2402/26Bhaskara VilasamVaidyasala,Panayamuttom,Nedumangadu,Thiruvananthapuram – 695 561It fails the test ‘pH’ as perAPI.Drugs TestingLaboratoryThiruvananthapura m9.PantoprazoleInj. BP 40 mgD0726/24- 25Kerala MedicalServices Corporation Ltd, Thycaud.P.O,ThiruvananthapuramThe sampledoes notcomply withBP. It fails the testParticulatecontaminatio n clarity and colour ofsolution.Drugs TestingLaboratoryThiruvananthapura m10.YogarajaGuggulu209/2103/223 yrs from mfg dateBhaskara VilasamVaidyasala,Panayamuttom,Nedumangadu,Thiruvananthapuram – 695 561It fails the testAlcoholSolubleExtractiveand pH asper APIDrugs TestingLaboratoryThiruvananthapura m11.PANCEF-OFT442401Jan-24Dec-25Aglomed Ltd. 51,Raipur , Roorkee -247661 . H.O : 702-A, Poonam Chambers , Dr. A.B Road , Worli , Mumbai – 400018,IndiaThe sample does notcomply withrespect tothe testparameters at S.No II d(Disintegratio n Test)Drug TestingLaboratorySrinagar (J&K) vide report on Form 13 bearing No.L/DA/2024-25/978 Dated: 07.08.2024Also Read:CDSCO Panel Approves Pfizer’s Protocol Amendment Proposal for antimicrobial drug Sisunatovir studyTo view the official notice, click the link below:https://medicaldialogues.in/pdf_upload/state-august-2024-253703.pdf