The Central Drug Regulatory Authority has released a report for the month of September on the quality of various drugs. 49 medicines failed in this standard test. These include cough syrups, calcium, vitamin D-3, multivitamins, and anti-allergy medications.
Most worryingly, all the medicines that doctors usually prescribe for the general patient have failed the CDSCO quality test. In CDSCO’s September list, Omarin D Capsule, Nimesulide + Paracetamol, Calcium 500, Vitamin D-3, Pentaprazole, Paracetamol Pediatric Oral Suspension, Acyclofenac, Cetrazine Syrup have failed standard tests. People usually use this medicine for fever, cold and cough.
CDSCO conducts standard testing of drugs available in the market every month. Among the drugs included in the ‘quality deficiency’ list are those of companies like Alchem Health Sciences, Aristo Pharmaceuticals, Camila Pharmaceuticals, Innova Captain, Hindustan Antibiotics and Ipka Laboratories.
Drug Controller General of India Dr Rajeev Singh Raghuvanshi said, “Periodical inspection is done to reduce the percentage of less effective drugs. He said that due to CDSCO’s action and monitoring on drugs, the effect of these fake drugs is reduced from the market. In the month of August, 53 failed the medical quality test.
53 drugs failed quality test : Among the drugs failing the quality standards are popular medications such as Shelcal (Vitamin C and D3 tablets), Pan-D (an antacid), Paracetamol tablets (500 mg), Glimepiride (an anti-diabetic drug), and Telmisartan (a high blood pressure medication). These drugs are produced by well-known pharmaceutical companies like Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, and Pure & Cure Healthcare, among others.
Metronidazole, a widely used drug for treating stomach infections and produced by PSU Hindustan Antibiotic Limited (HAL), failed the quality tests. Shelcal, distributed by Torrent Pharmaceuticals and manufactured by Pure & Cure Healthcare, and Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd were also flagged for failing quality checks.
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.
- List of drugs declared as Spurious/Adulterated/Misbranded: Check here for batch number and manufacturing date.
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)
- 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 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 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
(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
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