53 drugs, including commonly used Pan-D and Amoxicillin, flagged by CDSCO for failing quality tests, raises concerns about their safety and continued use.

The drugs listed include paracetamol, calcium and vitamin D3 supplements, as well as treatments for conditions such as high blood pressure and diabetes. These drugs were categorized as “Not of Standard Quality” (NSQ) following random testing by state drugs officials across multiple laboratories.

According to CDSCO officials, these monthly reports are part of an ongoing effort to ensure drug safety in India, though the majority of NSQ findings typically reflect minor issues and are not considered life-threatening.

As of September 20, three separate alerts highlighted a range of NSQ, adulterated, or spurious drugs. The first list named 48 medications, some of which had multiple samples tested from the same batch. In one instance, a cotton gauze roll was flagged for failing to meet specific standards.

The second list included 11 products, with two identified as ayurvedic or herbal remedies. The third alert named five drugs, three of which came from well-known manufacturers like Sun Pharma, Torrent, Glenmark, and Macleods. These companies, however, have denied any involvement in producing the flagged items, alleging they are counterfeit.

Some of the high-demand medications identified for quality issues include Paracetamol (500 mg tablets), vitamin supplements like Shelcal, Pan-D (a popular antacid), Glimepiride (a diabetes medication), and Telmisartan (used for hypertension). Notable manufacturers whose products were affected include Alkem Laboratories, Hetero Drugs, Hindustan Antibiotics Limited, and Pure & Cure Healthcare.

Among the flagged products, Metronidazole, commonly used to treat stomach infections, and Clavam 625 from Alkem Health Science were declared spurious by a Kolkata-based lab. In addition, Cepodem XP 50 Dry Suspension, often prescribed for bacterial infections in children, was found to be substandard.

In total, the CDSCO report listed 53 allopathic drugs that did not meet quality standards. The list also includes multiple samples from the same batches, along with spurious drugs, herbal remedies, and other non-drug items. In a separate decision, CDSCO also banned over 150 fixed-dose drug combinations in August due to health risks associated with their use.

This recurring vigilance is part of the regulator’s broader effort to maintain the safety and efficacy of medications across India.

List of 53 Drugs :

1. Amoxicillin And Potassium Clavulanate Tablets IP (Clavam 625) – M/s. Alkem Health Science
2. Amoxicillin & Potassium Clavulanate Tablets (Mexclav 625) – M/s. Meg Lifesciences
3. Calcium And Vitamin D3 Tablets IP (Shelcal 500) – M/s. Pure & Cure Healthcare Pvt. Ltd.
4. Metformin Hydrochloride Sustained-release Tablets IP (Glycimet-SR-500) – M/s. Scott-Edil Pharmacia Ltd.
5. Vitamin B Complex with Vitamin C Softgels – M/s. Asoj Soft Caps Pvt. Ltd.
6. Rifmin 550 (Rifaximin Tablets 550 mg) – M/s. Legen Healthcare
7. Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan – D) – M/s. Alkem Health Science
8. Paracetamol Tablets IP 500 mg – M/s. Karnataka Antibiotics and Pharmaceuticals Ltd.
9. Montair LC Kid (Montelukast Sodium & Levocetirizine Hydrochloride Dispersible Tablets) – M/s. Pure & Cure Healthcare Pvt. Ltd.
10. Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) (RL 500 ml) – M/s. Vision Parenteral Pvt. Ltd.
11. Fexofenadine Hydrochloride Tablets IP 120 mg – M/s. Maxtar Bio-Genics
12. Laxnorm Solution (Lactulose Solution USP) – M/s. Athens Life Sciences
13. Heparin Sodium Injection 5000 Units (Hostranil Injection) – M/s. Health Biotech Ltd.
14. Buflam Forte Suspension (Ibuprofen & Paracetamol Oral Suspension) – M/s. Ornate Pharma Pvt. Ltd.
15. Cepodem XP 50 Dry Suspension (Cefpodoxime Proxetil and Potassium Clavulanate Oral Suspension) – M/s. Hetero Labs Limited
16. Nimesulide, Paracetamol and Chlorzoxazone Tablets (NICIP MR) – M/s. HSN International
17. Rolled Gauze (Non-Sterilized) – M/s. Blazon India
18. Ciprofloxacin Tablets IP 500 mg (Ocif-500) – M/s. Ornate Labs Pvt. Ltd.
19. Nimesulide, Phenylephrine Hydrochloride & Levocetirizine Dihydrochloride Tablets (Nunim-Cold) – M/s. Unispeed Pharmaceuticals Pvt. Ltd.
20. Adrenaline Injection IP Sterile 1 ml – M/s. Alves Healthcare Pvt. Ltd.
21. Tab Nodosis – Steadfast Medishield Pvt. Ltd.
22. Haridrakhanda – Bhaskara Vilasam Vaidyasala
23. Pantoprazole Inj. BP 40 mg – Kerala Medical Services Corporation Ltd.
24. Yogaraja Guggulu – Bhaskara Vilasam Vaidyasala
25. PANCEF-OF – Aglomed Ltd
26. Kudajarishtam – Bala Herbals
27. Frusemide Injection IP 20 mg – Nestor Pharmaceuticals Ltd.
28. Moxymed CV – Alexa Pharmaceuticals
29. Cefixime Oral Suspension IP (Dry Syrup) – Nestor Pharmaceuticals Ltd.
30. Calcium and Vitamin D3 Tablets IP – M/s. Unicure India Ltd.
31. Metronidazole Tablets IP 400mg – M/s. Hindustan Antibiotics Ltd.Paziva -40 – M/s. Gnosis Pharmaceuticals Pvt. Ltd.
32. Pantomed -40 – Digital Vision 176
33. Glimepiride Tablets IP (2 mg) – M/s. Mascot Health Series Pvt. Ltd.
34. Alprazolam Tablets IP 0.25 mg (Erazol-0.25 Tablets) – M/s. Elikem Pharmaceuticals Pvt. Ltd.
35. Telmisartan Tablets IP 40 mg – M/s. Life Max Cancer Laboratories
36. INFUSION SET-NV – M/s. Medivision Healthcare
37. Olmesartan Medoxomil Tablets IP 40 mg – M/s. Life Max Cancer Laboratories
38. Amoxycillin and Potassium Clavulanate Tablets IP 625 mg (Renamega- CV 625) – M/s. Malik Lifesciences Pvt. Ltd.
39. Calcium 500 mg with Vitamin D3 250 IU Tablets IP – M/s. Life Max Cancer Laboratories
40. Diclofenac Sodium IP – M/s. Sara Exports Ltd.
41. Escitalopram and Clonazepam Tablets IP (Klozaps-ES Tablets) – M/s. Digital Vision
42. Phenytoin Sodium Injection USP – M/s. Health Biotech Ltd.
43. Paracetamol, Phenylephrine Hydrochloride and Cetirizine Hydrochloride Suspension (Cethel Cold DS Suspension) – M/s. Win Cure Pharma
44. Heparin Sodium Injection IP 25000 IU / 5ml – M/s. Scott-Edil Pharmacia Ltd.
45. Cefepime & Tazobactam for Injection (Crupime – TZ Kid Injection) – M/s. Cosmas Research Lab. Ltd.
46. Atropine Sulphate Injection IP (Atropine Sulphate) – M/s. Priya Pharmaceuticals
47. Salbutamol, Bromhexine HCI, Guaifenesin and Menthol Syrup (Acozil Expectorant) – M/s. Antila Lifesciences Pvt. Ltd.
48. Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) RL 500ml – M/s. Vision Parentral Pvt. Ltd.
49. Vingel XL Pro Gel (Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate, and Menthol Gel) – M/s. Universal Twin Labs
50. Atropine Sulphate Injection IP 2 ml – M/s. Nandani Medical Laboratories Pvt. Ltd.
51. Cefoperazone & Sulbactam For Injection (Todaycef 1.5 G) – M/s. Daxin Pharmaceuticals Pvt. Ltd.

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