Nearly 50 commonly used medicines were found to be of substandard quality, according to an alert issued by the Central Drugs Standard Control Organization (CDSCO). The organization labeled these medicines as "not of standard quality" (NSQ). The list featured 48 drugs, each identified by a unique batch number and manufacturing date.
The list included widely used medications such as antacids like Pan-D, Paracetamol, blood pressure medications, anti-diabetes drugs, vitamins, and calcium supplements. These products were manufactured by various companies, including Unicure India Ltd, Hetero Drugs, Health Biotech Ltd, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Life Max Cancer Laboratories, Pure & Cure Healthcare, and Meg Lifesciences.
The CDSCO released two lists: one comprising 48 drugs that failed quality tests and another highlighting five drugs that were declared “Spurious/Adulterated/Misbranded” in August 2024.
Drugs Declared as “Spurious/Adulterated/Misbranded”:
Pulmosil (Sildenafil Injection) Pantocid (Pantoprazole Tablets IP) Ursocol 300 (Ursodeoxycholic Acid Tablets IP) Telma H (Telmisartan 40 mg and Hydrochlorothiazide 12.5 mg Tablets IP) Defcort 6 (Deflazacort Tablets)Reason for CDSCO Alert:
The alert was issued because the manufacturers listed on the product labels reported that they did not produce the batches in question, classifying them as spurious drugs. This was noted in the CDSCO's “List of Drugs, Medical Devices, Vaccine, and Cosmetics declared as Spurious/Adulterated/Misbranded for the Month of August-2024.”
Here's the full-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 LactateSolution 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 XL 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
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
Indian Pharma Companies Under Scrutiny as 53 Drugs Fail Quality Tests