The alerts from the drug regulator are not meant to be disturbing or horrible. They primarily function as warning signs for businesses to self-correct or for regulators to take appropriate action. The Indian pharma regulator found that over 50 medications, including high blood pressure, calcium and Alert! Vitamin D3 tablets supplements, and anti-diabetes pills, did not pass quality testing.
As per the Central Medications Standards Control Organization (CDSCO) monthly drug alert list, 53 medications have been classified as “Not of Standard Quality (NSQ) Alert.”
State drug officers randomly sample the population each month to create NSQ notifications.
The NSQ and CDSCO
A list of medications that are determined to be “not of standard quality” (NSQ) during inspections is published by the regulatory body, the Central Drugs Standard Control Organization (CDSCO), once a month. State and federal officials randomly choose samples of different medications from the market and subject them to examinations regularly.
“Not our medications, scam goods”
Some significant pharmaceutical companies, including Sun Pharma Laboratories Limited, Glenmark Pharmaceuticals Private Limited, and Macleods Pharmaceuticals Limited, have responded to these revelations by claiming that the drugs with quality issues identified under their names are not theirs and may be fake. The CDSCO has said it will look into the matter more.
The CDSCO findings included concerns about medicine dissolving (i.e., the medicine’s exterior hardness and solubility properties), inaccurate information about the medicine, and the inappropriate amount of specific chemicals.
The 46 medications that CDSCO’s August 2024 report deemed “not of standard quality” are available here.
| SN | CDSCO’s August 2024 report (Durgs) |
| 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. | Paracetamol Tablets IP 500 mg |
| 8. | Montair LC Kid (Montelukast Sodium & Levocetirizine Hydrochloride Dispersible Tablets) |
| 9. | Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection) (RL 500 ml) |
| 10. | Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan-D) |
| 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. | Cepodem XP 50 Dry Suspension (Cefpodoxime Proxetil and Potassium Clavulanate Oral Suspension) |
| 16. | Buflam Forte Suspension (Ibuprofen & Paracetamol Oral Suspension) |
| 18. | Nimesulide, Paracetamol and Chlorzoxazone Tablets (NICIP MR) |
| 19. | Rolled Gauze (Non-Sterilized) |
| 20. | Ciprofloxacin Tablets I.P. 500 mg (Ocif-500) |
| 21. | Nimesulide, Phenylephrine Hydrochloride & Levocetirizine Dihydrochloride Tablets (Nunim-Cold) |
| 22. | Adrenaline Injection I.P. Sterile 1 ml |
| 23. | Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection) RL 500ml |
| 24. | Vingel XL Pro Gel (Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate and Menthol Gel) |
| 25. | Atropine Sulphate Injection IP 2 ml |
| 26. | Cefoperazone & Sulbactam For Injection (Todaycef 1.5 G) |
| 27. | Heparin Sodium Injection IP 25000 IU / 5ml |
| 28. | Cefepime & Tazobactam for Injection (Crupime – TZ Kid Injection) |
| 29. | Atropine Sulphate Injection I.P. (Atropine Sulphate) |
| 30. | Salbutamol, Bromhexine HCI, Guaifenesin, and Mentho Syrup(Acozil Expectorant) |
| 31. | Diclofenac Sodium IP |
| 32. | Escitalopram and Clonazepam Tablets IP (Klozaps-ES Tablets) |
| 33. | Phenytoin Sodium Injection USP |
| 34. | Paracetamol, Phenylephrine Hydrochloride and Cetirizine Hydrochloride Suspension (Cethel Cold DS Suspension) |
| 35. | Calcium 500 mg with Vitamin D3 250 IU Tablets IP |
| 36. | Amoxycillin and Potassium Clavulanate Tablets IP 625 mg
(Renamega- CV 625) |
| 37. | Olmesartan Medoxomil Tablets IP 40 mg |
| 38. | INFUSION SET-NV |
| 39. | Alprazolam Tablets IP 0.25 mg (Erazol-0.25 Tablets) |
| 40. | GLIMEPIRIDE TABLETS IP (2 mg) |
| 41. | Calcium and Vitamin D3 Tablets I.P. |
| 42. | Metronidazole Tablets IP 400mg |
| 43. | Telmisartan Tablets IP 40 mg |
| 44. | Telmisartan Tablets IP 40 mg |
| 45. | Telmisartan Tablets IP 40 mg |
| 46. | Telmisartan Tablets IP 40 mg |
