CDSCO issues alert on 48 failing pharmaceuticals

New Delhi | Desk: The Central Drugs Standard Control Organization (CDSCO) has alerted a notification issuing 48 identified pharmaceutical which have failed in drug test.

The CDSCO has declared these medicines Not of Standard Quality (NSQ). The NSQ alerts comes from monthly sampling conducted by state drug officers.

The list includes names of 48 drugs along with its unique batch numbers along with its manufacturing dates.

The Central drug regulator released two lists one of 48 drugs that failed the quality tests and the other had names of five drugs declared as “Spurious/Adulterated/Misbranded” in August 2024.

In August, the CDSCO banned over 156 fixed-dose drug combinations in the Indian market that are “likely to involve risk to humans”. These medicines included popular fever drugs, painkillers and allergy tablets.

List of 48 drugs declared “not of standard quality” in CDSCO’s August 2024 report

1. Amoxicillin And Potassium Clavulanate Tablets IP (Clavam 625)
2. Amoxycillin & Potassium Clavulanate Tablets (Mexclav 625)
3. Calcium And Vitamin D3 Tablets IP Shelcal 500 (Shelcal)
4. Metformin Hydrochloride Sustained-release Tablets IP (Glycimet-SR-500
5. Vitamin B Complex with Vitamin C Softgels
6. Rifmin 550 (Rifaximin Tablets 550 mg)
7. Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan-D)
8. Paracetamol Tablets IP 500 mg
9. Montair LC Kid (Montelukast Sodium & Levocetirizne Hydrochloride Dispersible Tablets)
10. Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection) (RL 500 ml)
11. Fexofenadine Hydrochloride Tablets IP 120 mg
12. Fexofenadine Hydrochloride Tablets IP 120 mg
13. Laxnorm Solution (Lactulose Solution USP)
14. Heparin Sodium Injection 5000 Units (Hostranil Injection)
15. Buflam Forte Suspension (Ibuprofen & Paracetamol Oral Suspension)
16. Cepodem XP 50 Dry Suspension (Cefpodoxime Proxetil and Potassium Clavulanate Oral Suspension)
17. Nimesulide, Paracetamol and Chlorzoxazone Tablets (NICIP MR)
18. Rolled Gauze (Non-Sterilized)
19. Ciprofloxacin Tablets I.P. 500 mg (Ocif-500)
20. Nimesulide, Phenylephrine Hydrochloride & Levocetirizine Dihydrochloride Tablets (Nunim-Cold)
21. Adrenaline Injection I.P. Sterile 1 ml
22. Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection) RL 500ml
23. Vingel L Pro Gel (Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate and Menthol Gel)
24. Atropine Sulphate Injection IP 2 ml
25. Cefoperazone & Sulbactam For Injection (Todaycef 1.5 G)
26. Heparin Sodium Injection IP 25000 IU / 5ml
27. Cefepime & Tazobactam for Injection (Crupime – TZ Kid Injection)
28. Atropine Sulphate Injection I.P. (Atropine Sulphate)
29. Atropine Sulphate Injection I.P. (Atropine Sulphate)
30. Atropine Sulphate Injection I.P. (Atropine Sulphate)
31. Atropine Sulphate Injection I.P. (Atropine Sulphate)
32. Salbutamol, Bromhexine HCI, Guaifenesin and Mentho Syrup(Acozil Expectorant)
33. Diclofenac Sodium IP
34. Escitalopram and Clonazepam Tablets IP (Klozaps-ES Tablets)
35. Phenytoin Sodium Injection USP
36. Paracetamol, Phenylephrine Hydrochloride and Cetirizine Hydrochloride Suspension (Cethel Cold DS Suspension)
37. Calcium 500 mg with Vitamin D3 250 IU Tablets IP
38. Amoxycillin and Potassium Clavulanate Tablets IP 625 mg

(Renamega- CV 625)

39. Olmesartan Medoxomil Tablets IP 40 mg
40. INFUSION SET-NV
41. Telmisartan Tablets IP 40 mg
42. Telmisartan Tablets IP 40 mg
43. Telmisartan Tablets IP 40 mg
44. Telmisartan Tablets IP 40 mg
45. Alprazolam Tablets IP 0.25 mg (Erazol-0.25 Tablets)
46. GLIMEPIRIDE TABLETS IP (2 mg)
47. Calcium and Vitamin D3 Tablets I.P.
48. Metronidazole Tablets IP 400mg

List of drugs declared as Spurious/Adulterated/Misbranded

1. Pulmosil (Sildenafil Injection)
2. Pantocid (Pantoprazole Tablets IP)
3. Ursocol 300 (Ursodeoxych olic Acid Tablets IP)
4. Telma H (Telmisartan 40 mg and Hydrochlorot hiazide 12.5mg Tablets IP)
5. Deflazacort Tablets (Defcort 6 Tablets)