18 formulations declared Not of Standard Quality as per data provided by states: CDSCO Drug Alert
New Delhi: In line with the 'Not of Standard Quality' data provided by states, the Central Drug Standard Control Organisation (CDSCO), in its recent drug safety alert, has flagged eighteen medicine batches for failing to qualify for a random sample test for September 2024.
The list of drugs declared not of standard quality include Moxica -250 [Amoxicillin Dispersible Tablets IP 250 mg manufactured by Indica Pharma, Neurotem-NT manufactured by Catasta Pharma, Loperamide Hydrochloride Tablets IP (JKMSCL Hospital Supply) manufactured by Karnani Pharma, Wintel 40 Tablets, Panlib 40 Tablets manufactured by Himalaya Meditek.
The list further includes Telmisartan Tab IP 40 mg, Pantoprazole Inj.BP 40 mg, Glimepiride Tab IP, Cough Syrup manufactured by Kerala Medical Services.
B. State Laboratories | |||||||
S.No | Product/Drug Name | Batch No. | Manufacturing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Neurotem-NT | CPT-2698 | Mar-24 | Feb-26 | Catasta Pharmaceuticals Plot No. 113, DIC, Industrial Area, Baddi Distt. Solan (H.P) Mrk. By : Cosway Biosciences Coprporate Office : Khasra No. 2054/1724, 1725 SCO No. 11 Baddi Barotiwala Road The. Baddi Distt. Solan H.P 173205 | The given Drug Sample does not comply to the contents of Assay with respect to Pregabalin ( 23.26% of claim) | Drug Testing Laboratory Srinagar (J&K) vide report on Form 13 bearing No. L/DA/2024- 25/1191 Dated: 05.09.2024. (Report attached as Annexure A) |
2. | Cefuroxime Axetil Tablets IP 500 mg (JKMSCL Supply) | JAK-23 | Jul-23 | Jun-25 | Agron Remedies Pvt Ltd Sarverkhera Moradabad Road Kashipur 244 713 (Uttarakhand) | The sample fails in the Description, Dissolution and Assay of Cefuroxime Axetil w.r.t the sample portion received as above | Combined Food & Drug Testing Laboratory Jammu (J&K) vide report on Form 13 bearing No. CFDL/J/2024-25/1120 Dated: 26.09.2024. (Report attached as Annexure B) |
3. | Loperamide Hydrochloride Tablets IP (JKMSCL Hospital Supply) | T-16201 | May-24 | Apr-26 | Karnani Pharmaceuticals Pvt. Ltd , 38 Pharma City , Selaqui Dehradun -248011 | The sample does not conform to IP with respect to the test for Dissolution & Assay | Drug Testing Laboratory Srinagar (J&K) vide report on Form 13 bearing No. L/DA/2024-25/1311 Dated: 27.09.2024. (Report attached as Annexure C) |
4. | Floxages-OZ (Ofloxacin and Ornidazole Tablets IP) | SPY41223 | 12/23 | 11/26 | Suraksha Pharma pvt.Ltd, 410, Karondi, Roorkee-247 667, Uttarakhand | It fails the test ‘Dissolution’ as per IP | Drugs Testing Laboratory Thiruvananthapuram |
5. | Wintel 40 Tablets | HTN257D | 04/24 | 03/26 | Himalaya Meditek pvt.Ltd, Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun - 248 197 | It fails the test ‘Dissolution’ as per IP | Drugs Testing Laboratory Thiruvananthapuram |
6. | Moxica -250 [Amoxicillin Dispersible Tablets IP 250 mg] | SD 243 | 08/23 | 07/25 | Indica Pharmaceuticals (P) Ltd, Bapunagar, Ahmedabad- 382 345 | It fails the test ‘Disintegration’ and ‘Uniformity of Dispersion’ specified in the Laboratory Protocol as per IP | Drugs Testing Laboratory Thiruvananthapuram |
7. | Frusemide Injection IP 20 mg | FRIB-03 | 01/24 | 12/25 | Nestor Pharmaceuticals Ltd, 11, Western Extension Area, Faridabad -121001 | It fails the test ‘Sterility’ as per IP | Drugs Testing Laboratory Thiruvananthapuram |
8. | Cloxacillin Sodium Capsules IP 250 mg | CLCA-04 | 04/23 | 03/25 | Nestor Pharmaceuticals Ltd, 11, Western Extension Area, Faridabad -121001 | The sample does not conform to IP Standards with respect to ‘Descriptive part’ of hard gelatin capsules and further tests cannot be performed due to reasons secified in the laboratory protocol | Drugs Testing Laboratory Thiruvananthapuram |
9. | Fluorometholone Eye Drops IP | CHE-3044 | 05/23 | 04/25 | Cotec Healthcare pvt.Ltd, K.H.No.593/1, Roorkee, Dehradun Highway, Kishanpur, Roorkee- 247 667, UK | It fails the test ‘Uniformity of Volume’ and ‘Assay’ as per IP | Drugs Testing Laboratory Thiruvananthapuram |
10. | Panlib 40 Tablets | HTN 102A | 01/24 | 12/25 | Himalaya Meditek pvt.Ltd, Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun | It fails the test Dissolution’ and ‘Assay’ as per IP | Drugs Testing Laboratory Thiruvananthapuram |
11. | B - Cidal 625 | UT232859 | 03/24 | 08/25 | VADSP Pharmaceuticals, Plot No. 124, EPIP Indl.Area, Phase 1, Jharmajri, Baddi (HP)- 174103 | The content of Clavulanic acid is not with in the limit of ‘Schedule V’ of Drugs and Cosmetics Act & Rules thereunder | Drugs Testing Laboratory Thiruvananthapuram |
12. | Trypsin, Bromelain & Rutoside Trihydrate Tablets [Flavoshine] | TTF24065 | 06/24 | 11/25 | Tiruvision Medcare, Plot No. 177, HPSIDC, Indl.Area, Baddi, Dist Solan HP 173 205 | The sample fails the test ‘Disintegration’ specified in the Laboratory protocol as per IP | Drugs Testing Laboratory Thiruvananthapuram |
13. | C Mont LC Kid 60 ml (Montelukast & Leveocetirizine Dihydrochloride syrup) | AL 23206 | 11/23 | 10/25 | Cian Healthcare Ltd, kh No.248, Village sisonia, Bhagwanpur, Roorkee, Haridwar, Uttarakhand- 247 661 | The content of montelukast is not within the limits of Schedule ‘V’ of Drugs & Cosmetics Act & Rules | Drugs Testing Laboratory Thiruvananthapuram |
14. | Yogaraja Guggulu Tablet | P 592324 | 10/23 | 09/26 | Oushadhi, The Pharmaceutical corporation (IM) , Kerala Ltd, Kuttanellur, Thrissur- 68 0014 | The sample does not conform to API Standards. It fails the tests ‘Total Ash’ as per API Standards. | Drugs Testing Laboratory Thiruvananthapuram |
15. | Telmisartan Tab IP 40 mg | D1153/24-25 | Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14 | The sample does not conform to IP Standards with respective to ‘Descriptive part’ of tablets and further tests cannot be performed due to above reasons. | Drugs Testing Laboratory Thiruvananthapuram | ||
16. | Pantoprazole Inj.BP 40 mg | D 0923/24- 25 | Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14 | It fails the test ‘Sterility’ specified in the laboratory protocol as per IP | Drugs Testing Laboratory Thiruvananthapuram | ||
17. | Glimepiride Tab IP | D1272/24-25 | Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14 | The sample fails the descriptive part for tablets as they are not sufficiently hard to withstand handling without crumbling or breaking and further tests cannot be performed due to above reason | Drugs Testing Laboratory Thiruvananthapuram | ||
18. | Cough Syrup | D 1278/24- 25 | Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14 | The sample fails the ‘Descriptive part’ for oral dosage forms of Schedule V of drugs and cosmetics Act and Rules, as the syrup contains red coloured suspended paticles | Drugs Testing Laboratory Thiruvananthapuram | ||
