Combiflam, D Cold Total and others found to be 'substandard' by drug regulator: All you need to know

New Delhi : The Central Drugs Standard Control Organisation (CDSCO) has found popular painkiller Combiflam and common cold medicine D Cold Total respectively, to be substandard in tests conducted last month and found that they failed different quality determining tests.

Combiflam which is a combination of ibuprofen and paracetamol, is one of Sanofi’s leading brands with annual sales of Rs 169.2 core.The CDSCO has found it to be substandard three times.D Cold Total is made by Reckitt Benckiser Healthcare India. Combiflam and D Cold Total are pills commonly found most Indian households.

Reports said Combiflam batch number A151195, manufactured in October 2015, failed the disintegration test. Last year, the drug regulator had found Combiflam to be substandard three times – in February, April and June – for failing the same test.

Sanofi claims the batch identified by the CDSCO in March 2017 was also manufactured in 2015, according to a report in The Indian Express.

The quality issues differ from drug to drug. An injection of gentamycin was found to contain particulate matter. Both the batches of Combiflam and D-Cold tablets failed because of "disintegration" while the ofloxacin samples, among other antibiotics, failed in "assay" or quantitative tests for their ingredients.

The 60 failed drug samples in the CDSCO's March 2017 safety bulletin is the highest number of drugs declared substandard in a single month's tests over the past year. The number of drugs labelled substandard ranged from 13 in July 2016 to 29 in November 2016.

A company spokesperson told the Indian Express, “Certain batches of Combiflam manufactured in 2015 were deemed substandard because the tablets showed a delay in the disintegration time. Essentially, there are several pharmaceutical parameters that are routinely assessed, one of which is to check the breakdown of a tablet in the human body. The batch identified by the CDSCO in March 2017 was also manufactured in 2015.”

The full list of the drugs and the problem batches is available on the CDSCO web

1. Stromix A 75 (Clopidogrel & Aspirin Capsules)
2. Nifesta – 10 (Nefidipine Sustained Release Tablets I.P.)
3. Primaquine Tablet I.P. 2.5 mg
4. Macmika 100 (Amikacin Sulphate Injection I.P. 2 ml)
5. Onset (Ondansetron Injection I.P.)
6. Amoxycillin & Cloxacillin Capsules
7. Micarti – DS (Glucosamine Capsules 500 mg)
8. Clobetasol Propionate Cream B.P. 10 gms
9. Gentamicin Injection I.P.
10. Ceftriaxone Injection I.P.
11. Injection of Etofylline & Theophylline
12. Nkacin – 500 (Amikacin Sulphate Injection I.P.)
13. Cefuroxime Axetil Tablets I.P. 500 mg
14. Metronidazole Tablets IP 200 mg
15. Fungal Diastase (1:1200)+Pepsin (1:3000)/15ml (Nutozyme Syrup)
16. Cetirizine Tablets IP (Ceriz Tablets)
17. Ofloxacin Dispersible Tablets 100mg (Oflox-100 DT)
18. Paracetamol, Caffeine anhydrous and Phenylephrine HCl Tablets (New D Cold Total Tablets)
19. Pantoprazole Gastro-Resistant Tablets IP (Panza- 40 Tablets)
20. Atenolol Tablets IP (Tenol-50 Tablets)
21. Calcium Carbonate with Vitamin D3 Tablets (Osocal- 500 Tablets)
22. Thiocolchicoside and Etoricoxib Tablets (EtoxtanMR Tablets)
23. Cefixime and Ofloxacin Tablets (Matcef-o Tablets)
24. Erythromycin Stearate Tablets IP 500mg
25. Combiflam (Ibuprofen and Paracetamol Tablets)
26. Etoril-5 (Ramipril Tablets I.P. 5mg)
27. Stromix A 75 (Clopidogrel & Aspirin Capsules 75mg+75mg)
28. Lactulose Solution USP 10g/15ml (B. No.: LSS5001B)
29. Lactulose Solution USP 10g/15ml (B. No.: LSS50038)
30. Cadilose (Lactulose Solution USP)
31. Lactulose Solution USP 10g/15ml (B. No.: LSS6001B)
32. Lactomed ( Lactulose Solution USP 10g)
33. Ciprofloxacin Tablets IP 250mg
34. X’ tor-10 (Atorvastatin Calcium)
35. Calcium Carbonate with Vitamin D3 Tablets
36. Doxylamine Succinate Tablets
37. Doxylamine Succinate Tablets
38. Doxylamine Succinate Tablets
39. Theo - AsthalinTablets
40. Lomotin Tablets
41. Pyra Tablets
42. Acloway – P Tablets
43. Carbamal - 200 Tablets
44. Elkaf – CM Expectorant
45. Ibuprofen Tablets
46. Zinc Sulphate Dispersible Tablets
47. Cipro - 500 Tablets
48. Elkaf – CM Expectorant
49. Fexonil - 180 Tablets
50. Doxylamine Succinate Tablets
51. Tramaford Tablets
52. Zinc Sulphate Dispersible Tablets
53. Aricepo – 200 Tablets
54. Riptin – 25 Tablets
55. Ferrous Sulphate & Folic Acid Tablets (LARGE)
56. Iron Tablets with Folic Acid (B. No.: IFL-27)
57. Ferrous Sulphate & Folic Acid Tablets
58. Ceftrixone & Sulbactum Injections
59. Iron Tablets with Folic Acid (B. No.: IFL-31)
60. Ferrous Sulphate & Folic Acid Tablets (LARGE) 

Input from Agencies