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Paracetamol, Shelcal, Pan D fail quality test, raise safety concerns: We ask an expert about the risks of taking these medicines

One of the major dangers of taking substandard medications is the risk of prolonged health issues.

Learn about the recent quality test failures of popular medicines like PCM and Pan D, and their potential health risks.Learn about the recent quality test failures of popular medicines like PCM and Pan D, and their potential health risks. (Source: Wikimedia Commons)

In a recent monthly report, the Central Drugs Standards Control Organization (CDSCO) raised significant safety concerns by declaring over 50 drugs as “not of standard quality.” The list included common medications like paracetamol, Pan D, and calcium supplements, with their unique batch number and manufacturing dates for easy identification. (see the full list at the end)

The CDSCO’s August 2024 report identified a range of medications under the “Not of Standard Quality (NSQ Alert)” category, including vitamin C and D3 tablets, Shelcal, vitamin B complex, vitamin C soft gels, anti-acid Pan-D, paracetamol tablets, the anti-diabetic drug Glimepiride, and the high blood pressure medication Telmisartan.

These drugs, 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, were identified through random sampling.

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Additionally, the CDSCO has flagged five drugs as “Spurious/Adulterated/Misbranded.” These products are counterfeit or contain incorrect ingredients, often imitating popular brands to deceive consumers. Examples include counterfeit versions of Glenmark’s Telmisartan and Sunpharma’s pantoprazole.

These NSQ alerts are generated based on random monthly sampling conducted by state drug officers and highlight the potential risks associated with substandard drugs.

The failures were attributed to substandard manufacturing practices, inadequate quality control, and contamination during production. Inconsistent levels of active pharmaceutical ingredients (APIs) in these medications amplify the problem.

According to Dr Narendra Singhla, Lead Consultant – Internal Medicine at the CK Birla Hospital, Delhi, substandard medicines pose serious health risks. “When the levels of APIs are incorrect or when contamination occurs, these drugs may not effectively treat conditions like pain or fever and could even cause adverse reactions,” Dr Singhla explained.

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Health risks associated with substandard medicines

One of the major dangers of taking substandard medications is the risk of prolonged health issues. PCM (paracetamol), for example, is widely used to treat pain and fever, but inconsistent API levels could lead to either ineffective treatment or potential overdosing, both of which have serious consequences.

Dr Singhla warns, “Prolonged use of such low-quality medications can lead to liver damage and kidney complications.” The stakes are even higher for individuals who rely on these medications for chronic conditions.

pill Fortunately, there are alternative medications for pain relief and fever reduction available on the market. (Source: AP Photo/Rick Bowmer)

What to do if you have the affected batches

If you suspect you are using an affected batch of PCM or Pan D, it is crucial to stop taking the medication immediately.

“It’s advisable to check the batch number and expiration date of your medication. If your product is part of the recalled batch, consult your doctor or pharmacist for guidance on what to do next,” advises Dr Singhla.

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Affected products should either be returned to the point of purchase or safely disposed of to avoid potential health risks. Continuing to use these medications could result in ineffective treatment and potential side effects.

To protect yourself from the risks posed by substandard medications, it’s essential to verify the authenticity of the medicines you purchase. Look for certifications like ISO (International Organization for Standardization) or WHO-GMP (World Health Organization Good Manufacturing Practice), which are quality indicators.

“Consumers must remain vigilant by checking these certifications and reporting any adverse reactions to regulatory authorities,” Dr Singhla emphasizes. He also calls for stricter quality control measures from manufacturers to prevent future issues and urges transparency and consumer safety.

What are the alternatives?

Fortunately, there are alternative medications for pain relief and fever reduction available on the market. Dr Singhla recommends consulting a healthcare provider to identify suitable replacements.

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“There are other reputable brands and medications available that have strict quality control standards. It’s important to always seek advice from a doctor before switching medications,” he added. Opting for alternatives with a track record of adhering to quality manufacturing processes can safeguard your health.

Full list of the drugs that failed the quality check

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

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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

DISCLAIMER: This article is based on information from the public domain and/or the experts we spoke to. Always consult your health practitioner before starting any routine.


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